System and method for cardiac valve repair

ABSTRACT

A delivery device for cardiac valve repair implants includes a delivery catheter and an extension member protruding from a distal end of the delivery catheter. The delivery device further includes a control arm assembly having pairs of control arms. Each pair includes a proximal control arm drivable from a handle assembly of the delivery device and a distal arm coupled to a distal end of the proximal control arm and a distal end of the extension member. Proximally driving each of the proximal control arms of the control arm assembly results in expansion of the control arm assembly and corresponding expansion of a cardiac valve repair implant coupled to the control arm assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Pat. Application No.17/550,660, filed Dec. 14, 2021, which is a continuation-in-part of U.S.Pat. Application No. 17/227,847, filed Apr. 12, 2021, now U.S. Pat. No.11,266,502 and titled “System and Method for Cardiac Valve Repair”,which is related to and claims priority under 35 U.S.C. § 119(e) fromU.S. Pat. Application No. 63/125,035, filed Dec. 14, 2020, and titled“System and Method for Cardiac Valve Repair”.

This application is also related to and claims priority under 35 U.S.C.§ 119(e) from U.S. Pat. Application No. 63/349,222, filed Jun. 6, 2022.

The entire contents of each of the foregoing applications areincorporated herein by reference for all purposes.

FIELD

The present disclosure relates to medical systems and methods forrepairing a cardiac valve. More specifically, the present disclosurepertains to a cardiac valve repair implant that is minimally invasivelydeliverable and implantable via an associated minimally invasivedelivery tool.

BACKGROUND

Cardiac valve regurgitation occurs when a cardiac valve does not closecompletely, causing blood to leak back through the valve. The causes ofregurgitation may vary. Functional regurgitation is caused by changes tothe heart geometry near the valve, where, for example, the heartenlarges, inducing both geometrical distortion around the valve annulusand insufficient leaflet coaptation during valve closure.

Degenerative regurgitation is caused by a disease of the valve itself,where, for example, the leaflets may thicken and be unable to sealcompletely. In both cases, the patient suffers because high-pressureblood in the ventricle regurgitates through the valve into thelow-pressure venous system.

Surgical repair and replacement may successfully treat tricuspid andmitral regurgitation, but surgery is costly and traumatic. Specifically,the surgical treatments require general anesthesia, a stopped heart withextracorporeal bypass, and either valve replacement or repair. Thesurgical treatments require painful recovery over a period ofapproximately three weeks. As a result, surgical treatment is often notperformed because cost, recovery time, pain, and, for older patients,mortality risk may be prohibitive.

Cardiac valves may also be repaired via percutaneous systems andmethods. For example, a percutaneous treatment may navigate a Nitinolclip between the valve leaflets to permanently clip the leafletstogether. The percutaneous clip procedure results in a relativelypain-free recovery within days, and this procedure has successfullytreated hundreds of thousands mitral regurgitation patients.Unfortunately, the percutaneous clip procedure is costly and difficultto perform, particularly by inexperienced operators. Further, thefeasibility of the percutaneous clip procedure for the tricuspid valveis unproven and may be less effective in a three-leaflet valve. Inaddition, the mechanisms of valvular regurgitation are multiple andfixing a single mechanism of disease (e.g., leaflet grasping) maytemporarily reduce the severity of regurgitation but not improve thenatural history of the disease (e.g., deterioration over time).

Accordingly, there is a need for a system for repairing a cardiac valvethat is simple to deliver, targets several disease componentssimultaneously, and improves overall results as compared to conventionaltreatments. There is also a need for a method of making such a repair.

SUMMARY

In one aspect of the present disclosure, a delivery device for cardiacvalve repair implants is provided. The delivery device includes adelivery catheter, an extension member protruding from a distal end ofthe delivery catheter and a control arm assembly releasably coupleableto a valve repair implant. The control arm assembly includes a controlarm pair that further includes a distal control arm coupled to andextending proximally from a distal end of the extension member and aproximal control arm coupled the distal control arm, the proximalcontrol arm extendable from the distal end of the delivery catheter tolaterally expand the control arm assembly.

In another aspect of the present disclosure, another delivery device forcardiac valve repair implants is provided. The delivery device includesa delivery catheter, an extension member protruding from a distal end ofthe delivery catheter and a control arm assembly releasably coupleableto a valve repair implant. The control arm assembly includes multiplecontrol arm pairs distributed circumferentially about the extensionmember. Each control arm pair includes a distal control arm coupled toand extending proximally from a distal end of the extension member and aproximal control arm coupled to the distal control arm, the proximalcontrol arm extendable from the distal end of the delivery catheter tolaterally expand the control arm assembly.

In another aspect of the present disclosure, a delivery device forcardiac valve repair implants is provided. The delivery device includesa delivery catheter, an extension member protruding from a distal end ofthe delivery catheter and a control arm assembly releasably coupleableto a valve repair implant. The control arm assembly includes a controlarm pair that further includes a distal control arm coupled to andextending proximally from a distal end of the extension member and aproximal control arm coupled the distal control arm, the proximalcontrol arm extendable from the distal end of the delivery catheter tolaterally expand the control arm assembly. The delivery catheter furtherincludes a distal portion including multiple, independently steerablesections.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D are illustrations of a system for repairing a cardiac valve,the system including a minimally invasive delivery tool and animplantable cardiac valve repair implant supported on a distal end ofthe delivery tool and that is deliverable and implantable via thedelivery tool.

FIG. 2 is a perspective distal-side view of the implantable cardiacvalve repair in an expanded state that is used when the implant isimplanted in the cardiac valve.

FIG. 3 is a perspective proximal-side view of the implantable cardiacvalve repair implant in the expanded state.

FIG. 4 is a perspective proximal-end view of the implantable cardiacvalve repair implant in the expanded state.

FIG. 5 is a side elevation view of the implantable cardiac valve repairimplant in the expanded state.

FIG. 6 is a distal plan view of the implantable cardiac valve repairimplant in the expanded state.

FIG. 7 is a side elevation view of the implantable cardiac valve repairimplant in a collapsed state.

FIG. 8 is an enlarged view of the distal region of the cardiac repairsystem of FIG. 1A.

FIG. 9 is a side cross-sectional elevation view of a sheath of thedelivery tool with the implantable cardiac valve repair implantmaintained in the collapsed state by being confined within the sheath,the implant being coupled to a distal end of a catheter that extendsthrough the sheath.

FIG. 10 is a view of the implantable cardiac valve repair implantimplanted in a target cardiac valve, as viewed from an atrial positionlooking towards the valve and the ventricle chamber below.

FIGS. 11A-11C are illustrations of a system for repairing a cardiacvalve and, more specifically, a plan view, side elevation view, and aplan view illustrating a range of motion of a delivery tool of thesystem, respectively.

FIG. 12 is a distal plan view of an implantable cardiac valve repairimplant in the expanded state and including a tension control line.

FIG. 13 is a photograph of an example implantable cardiac valve repairsystem in a disassembled configuration and including each of an implantand a delivery tool.

FIG. 14 is a side cross-sectional elevation view of a distal portion ofthe delivery tool of FIG. 13 .

FIG. 15 is a side cross-sectional elevation view of a distal portion ofthe delivery tool of FIG. 13 coupled to the implant.

FIG. 16 is a photograph of a distal perspective view of the implantcoupled to the delivery tool and in an expanded state.

FIG. 17 is a photograph of a detailed view of a connection between thedelivery tool and the tension control line of the implant and, morespecifically connection between a tension control member of the deliverytool and the control line of the implant using a release line of thedelivery tool.

FIG. 18 is a photograph of a second detailed view of a connectionbetween the delivery tool and the tension control line of the implant.

FIG. 19 is a photograph of a plan view of the delivery tool illustratingprotrusion of tension control members through a release catheter of thedelivery tool.

FIG. 20 is a side cross-sectional view of the delivery tool coupled tothe implant with the implant in an expanded configuration.

FIG. 21 is a side cross-sectional view of the delivery tool and theimplant during release of the implant from the delivery tool.

FIG. 22 is a side cross-sectional view of the delivery tool and theimplant following release of the implant from the delivery tool.

FIG. 23 is a side elevation view of a distal portion of an implant.

FIG. 24 is a side cross-sectional view of the distal portion of theimplant of FIG. 23 .

FIG. 25 is a perspective distal-end view of an implant including anocclusive assembly having an inner sheet.

FIG. 26 is perspective proximal-end view of the implant of FIG. 25 .

FIG. 27 is perspective distal-end view of a proximally concave implant.

FIG. 28 is a perspective proximal-end view of the implant of FIG. 27 .

FIG. 29A is a simplified elevation view of a proximally concave implant.

FIG. 29B is a simplified elevation view of a distally concave implant.

FIG. 29C is a simplified elevation view of an implant including aproximal portion having a proximally concave shape and a distal portionhaving a distally concave shape.

FIG. 30A is a simplified elevation view of a frustoconical implant.

FIG. 30B is a simplified elevation view of a planar implant.

FIG. 31 is a perspective distal-end view of an implant having a frameincluding arcuate petal portions connected by elongate longitudinalmembers.

FIG. 32 is a distal-end view of an implant having a frame includingdistally open arcuate petal portions.

FIG. 33 is a distal-end view of an implant having arcuate petal portionsformed by arcuate members extending between longitudinal members.

FIG. 34 is a distal-end view of an implant having arcuate petal portionsformed by arcuate members extending between longitudinal members andhaving an overall shape that includes a proximal portion having aproximally concave shape and a distal portion having a distally concaveshape.

FIG. 35A is a first distal-end view of an implant having arcuate petalportions formed by arcuate members extending between longitudinalmembers and having an overall shape that includes a proximal portionhaving a proximally concave shape and a distal portion having a distallyconcave shape.

FIG. 35B is a second distal-end view of the implant of FIG. 35Aincluding each of inner and outer sheets.

FIG. 36 is a distal-end view of an alternative delivery device accordingto the present disclosure in a collapsed state.

FIG. 37 is a distal-end view of the delivery device of FIG. 36 in anexpanded state.

FIG. 38 is a photograph of proximal a distal end of the delivery deviceof FIG. 36 including a valve repair implant coupled to the distal end ofthe delivery device.

FIGS. 39-44 are side views of the delivery device of FIG. 36 withvarious components removed to illustrated the internal construction ofthe delivery device.

FIG. 45A is a photograph of a side view of a distal end of the deliverydevice of FIG. 36 illustrating steerable sections of the deliverydevice.

FIGS. 45B and 45C are photographs of the delivery device of FIG. 36illustrating steering of a distal steering section of the deliverydevice.

FIGS. 45D and 45E are photographs of the delivery device of FIG. 36illustrating steering of a proximal steering section of the deliverydevice along a first plane.

FIGS. 45F-45H are photographs of the delivery device of FIG. 36illustrating steering of the proximal steering section along a secondplane, orthogonal to the first plane.

FIG. 46 is a photograph of a control assembly for steering the deliverydevice of FIG. 36 .

FIGS. 47-49 are detailed views of specific steering controls of thecontrol assembly of FIG. 46 .

FIG. 50 is a photograph illustrating a delivery device according to thisdisclosure with an implant coupled to a distal end and a sheath extendedover the implant.

FIG. 51 is a radiographic image of a delivery device according to thisdisclosure including a sheath with an embedded radiopaque marker.

FIGS. 52 and 53 are detailed views of a control assembly for selectivelyextending and retracting a sheath of the delivery device of FIG. 36 .

FIGS. 54A and 54B are photographs of the distal end of the deliverydevice of FIG. 36 including a deployed implant in a fully extended and ade-extended/retracted configuration, respectively.

FIG. 55 is a photograph of a control assembly for use with the deliverydevice of FIG. 36 , the control assembly including controls for each ofextending/retracting an extension member, expanding and collapsing acontrol arm assembly, and controlling tension of a cinch line.

FIG. 56 is a side view of a distal portion of the delivery device ofFIG. 36 with a control arm assembly in a collapsed state.

FIG. 57 is a detailed side view of a distal portion of the deliverydevice of FIG. 36 with the control arm assembly in an expanded state.

FIG. 58 is a detailed view of the delivery device showing coupling of aproximal and distal arm of the control arm assembly.

FIG. 59 is a detailed photograph illustrating coupling of an implant tothe control arm assembly via a cinch line.

FIG. 60 is a photograph of a control assembly of a delivery deviceaccording to the present disclosure.

FIG. 61 is a photograph of a control assembly and mount for use withdelivery devices of the present disclosure.

FIG. 62 is a flow chart illustrating a method of implanting a valverepair implant using a delivery device according to this disclosure.

FIG. 63A is a proximal-side perspective view of another implantaccording to the present disclosure.

FIG. 63B is a distal-side perspective view of the implant of FIG. 63A.

FIGS. 63C and 63D are distal views of the implant of FIG. 63A.

FIGS. 64A-C are isometric, distal-side, and side elevation views of aframe of the implant of FIG. 63A.

FIGS. 64D and 64E are additional views of the implant of FIG. 63Aindicating the location of specific structures of the implant.

FIG. 64F is a detailed view of a spoke of the frame of FIGS. 64A-64E.

FIG. 64G is a detailed view of an anchor member of the frame of FIGS.64A-64E,

FIGS. 64H and 64 l are detailed views of an outer petal portion of theframe of FIGS. 64A-64E.

FIG. 64J is a detailed view of inner petal portions of the frame ofFIGS. 64A-64E.

FIG. 64K is a detailed view of outer petal portions of the frame ofFIGS. 64A-64E.

FIGS. 64L and 64M are dimensioned side views of the frame of FIGS.64A-64E.

FIG. 64N is a detailed and dimensioned side view of a spoke of the frameof FIGS. 64A-64E.

FIGS. 65A and 65B are a distal view and a proximal-side perspectiveview, respectively of a laminated occluder.

FIG. 65C is a distal-side isometric view of the frame of FIGS. 64A-64Ewith the laminated occluder attached.

FIG. 65D is an exploded view of the frame and laminated occluder of FIG.65C.

FIGS. 65E and F are dimensioned distal and elevation views of the frameand laminated occluder of FIG. 65C.

FIG. 66A is a distal-side perspective view of an alternative laminatedoccluder including a proximally convex back.

FIG. 66B is a proximal-side perspective view of the alternativelaminated occluder of FIG. 66A.

FIG. 67A is an elevation view of the implant of FIG. 63A illustrating anouter sheet coupled to the implant frame.

FIGS. 67B-D are detailed views of the coupling between the outer sheetand frame of the implant of FIG. 63A.

FIG. 68 illustrates the outer sheet prior to attachment to the frame.

FIG. 69A is a proximal-side perspective view of the implant of FIG. 63Aillustrating eyelets distributed about the frame of the implant.

FIG. 69B is a detailed view of the implant of FIG. 63A furtherillustrating eyelets of the implant.

FIG. 70 and FIGS. 71A-71C are views of the eyelets of FIGS. 69A-69B.

FIG. 72 is a detailed view of a junction of the frame of the implant ofFIG. 63A including a slot for receiving an eyelet.

FIGS. 73A and 73B are cross-sectional views of the implant of FIG. 63Aillustrating coupling of the eyelet to the frame with FIG. 73B furtherillustrating coupling of the implant to a delivery device control arm.

FIG. 74 is an elevation view of an example delivery system and implant,the delivery system including a catheter assembly.

FIG. 75 is an elevation view of an internal tubular member of thecatheter assembly of FIG. 74 .

FIGS. 76A-76D are detailed views of specific sections of the internaltubular member of FIG. 75 .

FIGS. 77A and 77B are perspective views of a mounting assembly anddelivery system illustrating insertion of the delivery system.

FIGS. 78A-78C are additional views of the mounting assembly and deliverysystem of FIGS. 77A and 77B illustrating rotation of the deliverysystem.

FIGS. 79A and 79B are elevation views of a handle assembly and a distalend of a delivery system illustrating distal extension of an implantcoupled to the delivery system.

FIGS. 79C and 79D are elevation views of the handle assembly and thedistal end of the delivery system illustrating distal retraction of theimplant coupled to the delivery system.

FIGS. 80A and 80B are internal views of the handle assembly in theextended and retracted states, respectively.

FIGS. 81A and 81B are elevation views of the handle assembly and thedistal end of the delivery system illustrating the system in a collapsedstate.

FIGS. 81C and 81D are elevation views of the handle assembly and thedistal end of the delivery system illustrating the system in an expandedstate.

FIG. 82A is an internal view of the handle assembly in the collapsedstate.

FIG. 82B is a detailed view of a cinch line mechanism of the handleassembly.

FIG. 82C is an internal view of the handle assembly in the expandedstate.

FIGS. 83A-83H are proximal views of an implant coupled to a deliverysystem during progressive stages of an implant release sequence.

FIG. 84 is a perspective view of a handle assembly including a controlring for releasing an implant from a delivery system.

FIGS. 85A and 85B are internal views of the handle assembly of FIG. 84 .

FIG. 85C is a proximal internal view of the handle assembly of FIG. 84 .

FIGS. 86A-86D proximal internal views of the handle assembly of FIG. 84during progressive stages of an implant release sequence.

FIG. 87A is an isometric view of a mounting assembly for use withdelivery devices according to this disclosure.

FIG. 87B is an isometric view of a handle mount assembly of the mountingassembly of FIG. 87A.

FIG. 87C is a detailed view of a rail assembly of the of the mountingassembly of FIG. 87A.

FIGS. 87D and 87E are isometric views of a rail assembly, carriageassembly, and interface of the mounting assembly of FIG. 87A in adecoupled state.

FIGS. 87F and 87G are isometric views of an interface block of themounting assembly of FIG. 87A in a disengaged and engage state,respectively.

FIGS. 87H and 87 l are perspective views of the mounting assembly ofFIG. 87A including a sterile drape.

FIGS. 87J and 87K are isometric views of a carriage assembly of themounting assembly of FIG. 87A.

FIG. 87L is a detailed view of the carriage assembly as shown in FIG.87K.

FIG. 87M is an isometric view of a yoke of the mounting assembly of FIG.87A.

FIG. 87N is an isometric view of a structural coupling of the mountingassembly of FIG. 87A.

FIG. 88A is an isometric view of a distal portion of a delivery deviceand implant according to an implementation of this disclosure.

FIG. 88B is the view of FIG. 88A with select components removed tobetter illustrate a control arm assembly.

FIG. 88C is a side elevation view of the control arm assembly of FIG.88B.

FIGS. 88D and 88E are detailed views of a joint between control arms ofthe control arm assembly of FIG. 88B.

FIG. 88F is a partially dimensioned side view of the control armassembly of FIG. 88B.

FIG. 89 is a side view of the distal portion of the delivery device ofFIG. 88A with the control arm assembly in a collapsed and retractedconfiguration.

FIG. 90 is a flow chart illustrating an example method of delivering acardiac valve repair implant according to this disclosure.

DETAILED DESCRIPTION

For a brief overview of the cardiac valve repair system 10 disclosedherein, reference is made to FIGS. 1A-1D. In particular, FIG. 1A is aphotograph of the cardiac valve repair system 10 while FIGS. 1B-1D areisometric, plan, and side elevation views, respectively of the valverepair system 10. As can be understood from FIG. 1A, the system 10includes a delivery and deployment tool 15 and an implantable cardiacvalve repair device or implant 20 supported on a distal end 25 of thetool 15. The tool 15 includes a proximal end 30 opposite the tool distalend 25. The tool proximal end 30 includes a control handle 35 used by aphysician to manipulate the tool 15 in positioning the implant 20 at thetarget site and deploying the implant 20 within the target site, whichis a cardiac valve in need of repair, as discussed in detail later inthis Detailed Description. In one embodiment, the tool 15 is used forminimally invasive delivery and deployment of the implant 20 in thecardiac valve in need of repair.

The system and its implant are advantageous in that the implant may bedelivered and deployed at the target site via an antegrade percutaneousroute (e.g., a trans-femoral or trans-jugular route) with the patientconsciously sedated during the procedure. It is anticipated theimplantation stage may take less than 60 minutes, and the implant anddelivery system will have a cost substantially less expensive than priorcardiac valve repair systems. Finally, the regurgitation grade affordedby a cardiac valve repair completed via the implant 20 disclosed hereinwill be 2+ or lower. Accordingly, the cardiac repair system 10 is asignificant improvement over prior art systems as it is atraumatic,materially less expensive and less time intensive, all while providing asignificant improvement in the reduction of regurgitation.

I. Cardiac Valve Repair Implant

To begin a detailed discussion of the cardiac valve repair implant 20,reference is made to FIGS. 2-6 , which are various views of anembodiment of the implant 20 when the implant is in an expanded statethat exists when the implant is implanted in the cardiac valve to berepaired. As illustrated in these figures, the implant includes distalend 40 and a proximal end 45. The distal end 40 serves as the leadingend of the implant 20 during implantation, as can be understood fromFIGS. 1A-1D.

As illustrated in FIGS. 2-6 , the implant 20 further includes a centraloccluder 50, a frame 55 and a thin sheet 60 (also referred to herein asa thin layer 60) supported on the frame. The frame 55 extends proximallyfrom a proximal end 65 of the central occluder 50. When in the expandedstate, the frame 55 radiates laterally outwardly relative to a centrallongitudinal axis 70 (see FIG. 5 ) of the implant 20, and the thin sheet60 forms an annular surface 62 supported on the expanded frame 55. Theannular surface 62 has a distal radially inward edge 63 and a proximalradially outward edge 64. The distal radially inward edge 63 defines acentral opening 66 in the thin sheet 60 and the implant 20. The proximalradially outward edge 64 forms the extreme proximal radially outwardboundary of this embodiment of the implant when in the expanded state.The central longitudinal axis 70 passes through the extreme distal tip75 of the central occluder 50 and a center point 80 (see FIG. 4 ) of theproximal end 65 of the central occluder. In light of the foregoing andin at least certain embodiments, the frame 55 is generally designed tosit on the floor of the atrium, to induce annular reduction, and toproduce a neo-annulus.

As can be understood from FIGS. 2-6 , in addition to being annular, theannular surface 62 may also be conical, or relatively so (e.g.,parabolic), such that its proximal side, which faces the atrial chamberwhen the implant 20 is implanted in the target cardiac valve as depictedin FIG. 10 , serves as a funnel arrangement distally leading from theatrial chamber towards the central opening 66 of the implant 20 and thevalve opening distal the central opening 66. Similarly, the distal sideof the annular surface 62 may also be conical to generally make matingsurface contact with the semi-conical regions of the atrial wall surfaceand surrounding annular region of the target cardiac valve, as can beunderstood from FIG. 10 .

When in the collapsed state, as depicted in FIG. 7 , which is a sideview of the implant collapsed to allow its delivery to the target sitevia the tool 15, the frame 55 and thin sheet 60 collapse symmetricallyabout the central longitudinal axis 70. Thus, a comparison of theimplant 20 in FIGS. 2-6 when in the expanded state to the implant 20 inFIG. 7 in the collapsed state indicates that the implant can transitionfrom the collapsed state to the expanded state similar to an umbrella.

As can be understood from FIG. 9 and discussed in greater detail laterin this Detailed Disclosure, during delivery, the implant 20 ismaintained in the collapsed state of FIG. 7 by the tool 15 so as toallow the implant to be negotiated through the patient vascular systemand into an atrial chamber of the heart for implantation of the implantwithin a target cardiac valve. For example, with the implant 20maintained in the collapsed state by virtue of being confined within atubular sheath 76 of the delivery tool 15, the implant may be deliveredand deployed at the target site via an antegrade percutaneous route(e.g., an antegrade trans-femoral or trans-jugular route) with thepatient consciously sedated during the procedure.

Upon being properly positioned in the target cardiac valve for repair,the physician actuates the tool 15 such that the tool no longermaintains the implant 20 in the collapsed state, as can be understoodfrom FIG. 1A. Since the frame 55 of the implant 20 is biased toself-expand into the expanded state of FIGS. 2-6 , the implantself-expands into the expanded state to anchor itself within the targetcardiac valve and reduce regurgitation, as shown in FIG. 10 .

Returning to FIGS. 2-6 , it can be understood that the central occluder50 may take the form of a bullet or conical shape. In doing so, thecentral occluder may have a cylindrical side 85 extending distally fromthe central occluder proximal end 65 and then transitioning to abullnose 90 that distally extends to the central occluder extreme distaltip 75. Such a bullet or conical shape results in the central occluder50 being atraumatic for delivery and implantation purposes. Further,such a shape facilitates the cylindrical side 85 of the central occludersubstantially sealing against the cardiac valve leaflets, therebymaterially reducing, if not eliminating, central regurgitation past thecardiac valve leaflets.

Without limitation and depending on the embodiment, the central occluder50 may be formed from polytetrafluoroethylene (PTFE), polyether etherketone (PEEK), acetal, silicone, nylon, polyethylene, polypropylene,polyethylene terephthalate (PET), polyurethane, or other thermoplasticelastomers. In certain embodiments, the material of the central occluder50 may be angio- and/or echolucent.

In certain embodiments, the central occluder 50 may be filled withsaline, a combination of saline with a radio-opaque contrast agent, orother fluid. In such embodiments, the central occluder 50 may bedelivered in a first configuration having a reduced diameter and thenexpanded into a second configuration having an increased diameter byintroducing fluid into the central occluder 50 following delivery. Theamount of saline delivered during implantation may be determined inreal-time, for example, by monitoring a size of the central occluder 50,e.g., using an X-ray image, and/or by monitoring a reduction ofregurgitation, e.g., using ultrasound imaging.

In certain embodiments and without limitation, the central occluder 50may be formed from a material having a durometer from and including 10Ato and including 100D, from and including 10D to and including 100D, orfrom and including 40D to and including 80D. In one specific embodiment,the material of the central occluder 50 has a durometer of 80D. Asindicated in FIG. 5 , the central occluder may have an overall diameterDO that, in certain embodiments and without limitation, may be betweenapproximately 5 millimeters (mm) and approximately 25 mm, betweenapproximately 5 mm and approximately 15 mm, or between approximately 8mm and approximately 12 mm. The central occluder 50 further has anoverall length LO from its proximal end 65 to its extreme distal tip 75that, in certain embodiments and without limitation, may be betweenapproximately 5 mm and approximately 40 mm or between approximately 10mm and approximately 20 mm. The bullnose 90 may have a length LB that,in certain embodiments and without limitation, may be betweenapproximately 2.5 mm and approximately 12.5 mm, between approximately2.5 mm and approximately 7.5 mm, or between approximately 4 mm andapproximately 6 mm. In certain embodiments and without limitation, theradius of curvature R of the bullnose 90 may be between approximately2.5 mm and approximately 12.5 mm, between approximately 2.5 mm andapproximately 7.5 mm, or between approximately 4 mm and approximately 6mm. The general shape of the bullnose 90 may also vary acrossembodiments. For example, the bullnose 90 may have any of a parabolicprofile, a conical profile, a spherical profile, or any other atraumaticprofile. In other example embodiments, the bullnose 90 may have atrihedral, frustoconical shape, or other non-rounded shape. In certainexample embodiments, the central occluder 50 may have a triangular ortri-lobe shape that provides surfaces for sealing against respectiveleaflets. In yet another example, the central occluder 50 may have arounded double-concave shape. In still other embodiments, the centraloccluder 50 may be configured to allow distention of a distal portion ofthe frame 55, thereby facilitating reintervention (e.g., valveimplantation). In yet other embodiments, the central occluder 50 mayinclude a frame (e.g., inner struts) covered in a flexible material,such as, but not limited to expanded polytetrafluoroethylene (ePTFE),polyester fabric, or a similar material. In such embodiments, theflexible covering may allow the central occluder 50 to be compressed fordelivery but to expand once positioned in the native valve to occludeand reduce regurgitation.

As can be understood from FIG. 5 , in one embodiment, the centraloccluder 50 may have an overall diameter DO of approximately 10 mm, andits overall length LO may be approximately 16 mm. Additionally, thebullnose 90 may have an overall length LB of approximately 5 mm, and theradius of curvature of the bullnose 90 may or may not graduallytransition over its length LB from proximal to distal. For example, theradius of curvature R may have a maximum value from approximately 2.5 mmto approximately 15 mm as measured from a center of curvature C to thedistal tip 75 of the central occluder 50 but may transition to a radiusof curvature R that is between approximately 2.5 mm and approximately 10mm, but less than or equal to the maximum, at a location proximal thedistal tip 75. In one embodiment, however, the bullnose 90 may have aconstant radius of curvature of approximately 5 mm.

As can be understood from FIGS. 2-6 , the thin sheet 60 is supported onthe frame 55 and secured thereto. For example and without limitation, incertain embodiments the thin sheet 60 may be secured to the frame 55 bysuturing the skirt against an inner surface and/or an outer surface ofthe frame 55. In other implementations, the thin sheet 60 may include acuff or similar folded structure that is folded over an end of the frame55. In still other implementations, the thin sheet 60 may be secured tothe frame by sewing, welding, gluing/adhering, stapling, or any othersuitable securement method or combination of securement methods.Depending on the embodiment, the thin sheet 60 may be on the distal sideof the frame 55, the proximal side, or both such that the frame extendsthrough and along the thin sheet. In one embodiment, the frame 55 iscovered with a thin sheet 60 on the distal side of the frame where theframe contacts atrial tissue when the implant 20 is implanted in thetarget cardiac valve.

Depending on the embodiment, the thin sheet 60 may be formed of orinclude a woven or knit material or fabric that encourages tissueingrowth. The porosity of the fabric of the thin sheet 60 assists inreducing commissural tricuspid regurgitation. Further reduction ofcommissural tricuspid regurgitation is provided by the angulation of theframe 55, which provides close contact with the commissures in acircumferential manner. For example, with the implant 20 implanted inthe target cardiac valve, tissue in-growth into the fabric of the thinsheet 60 buttresses the myocardium, helping to keep the tissue fromexpanding further and reducing the potential of future regurgitation.

The fabric can be made from various methods, i.e. knitting, weaving,single or multiple layers. These fabrics can be laminated together witha polymer to make a composite structure, i.e. two pieces of knit (highporosity) with a polymer coating like silicone or urethane. Examplematerials for the woven or knit materials may include, withoutlimitation, polyester, polypropylene, polyethylene, etc. The thin layer60 may have a material thickness of between approximately 0.03 mm andapproximately 1 mm, between approximately 0.05 mm and approximately 0.2mm, or between approximately 0.07 mm and approximately 0.12 mm. In oneexample embodiment, the thickness of the thin layer 60 is approximately0.2 mm. In another example embodiment, the thickness of the thin layer60 is approximately 0.55 mm. In one embodiment, an additional textilelayer may be added on the proximal side of the thin sheet 60 to create asmooth surface to minimize clot formation in an atrial chamberimmediately adjacent the cardiac valve in which the implant 20 isimplanted.

As indicated in FIGS. 5, 6 and 7 , the thin sheet 60 has an outerdiameter DS. In certain embodiments, the outer diameter DS may bebetween approximately 40 mm and approximately 80 mm, betweenapproximately 50 mm and approximately 70 mm, or between approximately 55mm and approximately 65 mm. The thin sheet 60 has a radial width RW. Incertain embodiments, the radial width RW may be between approximately 10mm and approximately 30 mm, between approximately 13 mm andapproximately 23 mm, or between approximately 17 mm and approximately 19mm. The thin sheet 60 has a central opening 66 with an inner diameterDI. In certain embodiments, the inner diameter DI may be betweenapproximately 20 mm and approximately 60 mm, between approximately 25 mmand approximately 45 mm, or between approximately 28 mm andapproximately 32 mm. For example, . In one embodiment, the thin sheet 60has an outer diameter DS of approximately 60 mm, a radial width RW ofapproximately 18.2 mm, and a central opening 66 with an inner diameterDI of approximately 30 mm. Due to its configuration, when the implant 20is implanted in the target cardiac valve, the circumferential fabric ofthe thin sheet 60 covers a portion of the outer leaflet commissures toblock leaks at the edges of the commissures.

As shown in FIGS. 2-6 , the frame 55 includes spokes 95, arcuate petalportions 100 and protruding anchor members 105. The frame 55 may be madefrom a variety of super-elastic and/or shape memory materials,including, for example, nickel-titanium alloys (e.g., Nitinol), whichmay be laser cut from a tube or in the form of drawn wire. The featuresdefined in the shape memory materials may be defined therein via variouscutting methods known in the art, include laser, water jet, electricaldischarge machining (EDM), stamping, etching, milling, etc.

In one embodiment, the frame 55 is made of super-elastic, shape memorynickel titanium alloy (e.g., Nitinol). Regardless of which shape memorymaterial is employed, the shape memory aspects of the frame 55 allow theframe and, as a result, the implant 20 to self-bias from the collapsedstate (see FIG. 7 ) to the expanded state (see FIGS. 2-6 ) when notphysically maintained in the collapsed state by the delivery tool 15.

In various embodiments, the frame 55, central occluder 50 and the restof the implant 20 remain implanted as a unit in the target cardiacvalve. In other words, the implant 20 is implanted and remains so asconfigured in FIGS. 2-6 .

There may be situations where it is desirable to remove the centraloccluder and then implant a replacement valve in the target cardiacvalve. Accordingly, in alternate embodiments, the central occluder 50and frame spokes or struts 95 may be removable after implantation,leaving the surrounding annular surface 62 of the implant in place, theannular surface 62 being formed by and including the frame arcuate petalportions 100 and the thin sheet 60 supported thereon. In suchembodiments, a circumferential suture connection may exist between thespokes 95 and the rest of the frame 55 radially outward of the spokes95. Thus, this circumferential suture connection may be cut and thecentral occluder 50 and its spokes 95 may be removed through a catheter,leaving the annular portion of the implant, which then acts as an“annuloplasty” frame.

As indicated in FIG. 7 , when the implant 20 is in the collapsed state,the spokes 95 proximally extend from the proximal end 65 of the centraloccluder 50 to the arcuate petal portions 100. In doing so, the spokes95 are substantially parallel with, and extend along and near to, thecentral longitudinal axis 70 of the implant 20. As can be understoodfrom FIG. 7 , when the implant is in the collapsed state, each spoke 95has a length L from the central occluder proximal end 65 to a distalboundary of an arcuate petal portion 100. In certain embodiments, thelength L may be between approximately 10 mm and approximately 40 mm orbetween approximately 15 mm and approximately 22 mm, with one embodimenthaving a length L of approximately 19 mm. As indicated in FIG. 7 , theframe 55 in the collapsed state thus has an overall length OL that isthe sum of the length L (shown in FIG. 7 ) and the radial width RW(shown in FIGS. 5 and 7 ), the candidate dimensions for the radial widthRW being as discussed above with respect to FIG. 5 .

As shown in FIGS. 2-6 , when the implant 20 is in the expanded state,the spokes 95 proximally extend from the central occluder proximal end65 and laterally radiate away from the central longitudinal axis 70 ofthe implant 20 to the arcuate petal portions 100. In doing so, thespokes 95 have a radius of curvature RC of between approximately 5 mmand approximately 20 mm, between approximately 10 mm and approximately18 mm, or between approximately 15 mm and approximately 16 mm with oneembodiment having a radius of curvature RC of approximately 15 mm, ascan be understood from FIG. 5 .

Depending on the embodiment, the frame 55 may include betweenapproximately 3 and approximately 15 spokes 95. In certain embodiments,the number of spokes 95 and gaps therebetween may be selected tofacilitate passage of other tools and devices past the frame 55.Embodiments may include spokes 95 with various cross-sectional shapes;however, in at least certain embodiments, spokes 95 have an annularsector cross-sectional shape, such as illustrated in Inset A-A of FIG. 6. In such embodiments, the cross-sectional shape of the spokes 95 may bedefined by each of a strut width SW (defined as the maximum width of thespoke) and a wall thickness WT of the spokes 95. The spokes 95 may befurther defined by a cross-sectional radius of curvature CSR as measuredto a centerline CL of each spoke. In certain implementations, the wallthickness WT may be between approximately 0.2 mm and 0.8 mm, betweenapproximately 0.3 mm and approximately 0.7 mm, or between approximately0.4 mm and approximately 0.6 mm. In addition, in certainimplementations, the spokes 95 may conform to certain spoke aspectratios, which, in the context of the spokes 95 refers to the ratio ofthe wall thickness WT to the strut width SW. For example, and withoutlimitation, embodiments may have a spoke aspect between 4:0.5 and 1:2,between 3:1 and 1:1.2, or between 2:1 and 1:1. In embodiments, thecross-sectional radios of curvature CSR may be between approximately 2mm and approximately 6 mm, between approximately 3 mm and approximately5 mm, or between approximately 3.5 mm and approximately 5 mm. In oneparticular embodiment, the frame 55 is made of Nitinol and the frame 55has 12 spokes 95, with each spoke 95 having a wall thickness WT ofapproximately 0.46 mm, an aspect ratio of approximately 2:1 (resultingin a strut width SW of approximately 0.23 mm), and a cross-sectionalradius of curvature CSR of approximately 5 mm. In certain embodiments,the spokes 95 may be arranged such that they extend distally from theframe 55 at an angle such that the thin sheet 60 occludes coaptationgaps. In certain embodiments of the present disclosure, each of thespokes 95 may be dimensionally identical; however, in other embodiments,one or more of the spokes 95 may differ in any of the variouscharacteristics noted above.

As illustrated in FIGS. 2-6 , each arcuate petal portion 100 is locatedbetween a pair of spokes 95 and forms a section of the circumference ofa radially outward half of the expanded frame 55. As can be understoodfrom FIG. 5 , unlike the spokes 95, which are curved in the expandedstate, the arcuate petal portions 100 in the expanded state aregenerally straight in a laterally radiating direction and haveapproximately the same radial width RW as that of the thin sheet 60.Each petal portion 100 has an outer arcuate member 110 and an innerarcuate member 115, both of which point radially outward. These arcuatemembers 110, 115 intersect at a junction portion 120 that extends from arespective spoke 95 and surrounds a protruding anchor member 105 thatdistally projects from a distal side of its junction portion 120.

Depending on the embodiment, the frame 55 may include different numbersof petal portions 100. For example, in certain example embodiments, theframe 55 may include between 3 and 18 petal portions 100, between 6 and15 petal portions 100, or between 10 and 14 petal portions 100. In oneembodiment, the frame 55 has 12 petal portions 100. Similarly, the frame55 may include different numbers of protruding anchor members 105. Forexample, in certain example embodiments, the frame 55 may includebetween 6 and 60 protruding anchor members 105, between 12 and 36protruding anchor members 105, or between 18 and 30 protruding anchormembers 105. In one embodiment, the frame 55 has 24 protruding anchormembers 105.

The frame 55 engages the atrial tissue via the protruding anchor members105, which may be in the form of small barbs. The protruding anchormembers 105 are designed to securely engage the atrial tissue withoutpenetrating through the tissue or to the coronary vessels. Depending onthe embodiment, the protruding anchor members or barbs 105 may be curvedto slide before engaging tissue. There may be one row or multiple rowsof retention barbs 105.

As indicated in the enlarged view of a junction portion 120 of FIG. 6 ,each protruding anchor member 105 is defined in the surrounding junctionportion 120 via a slot 125 that extends around the protruding anchormember 105 such that the anchor member 105 is peninsular in thesurrounding junction portion 120. A radially inward end 105A extendsuninterrupted to the rest of the surrounding junction portion 120 and isopposite a radially outward free end 105B of the anchor member 105, theradially outward free end 105B forming a tip of the protruding anchormember 105. As can be understood from FIGS. 2, 3 and 5 , the radiallyoutward free end of the anchor member projects distally from the rest ofthe frame 55.

Depending on the embodiment, each protruding anchor member 105 may havea length of between approximately 0.5 mm and approximately 6 mm, betweenapproximately 1 mm and 4 mm, or between approximately 1 mm andapproximately 3 mm. Similar to the spokes 95, the protruding anchormembers 105 may have various cross-sectional shapes. In at least certainembodiments, the protruding anchor members 105 have an annular sectorcross-sectional shape, similar to that discussed above in the context ofthe spokes 95 and as illustrated in Inset A-A of FIG. 6 and which isreferenced for purposes of the following discussion. Like the spokes 95,the cross-sectional shape of the protruding anchor members 105 may bedefined by each of a strut width SW (defined as the maximum width of thespoke) and a wall thickness WT. The protruding anchor members 105 may befurther defined by a cross-sectional radius of curvature CSR as measuredto a centerline CL of each anchor member. In certain implementations,the wall thickness WT may be between approximately 0.2 mm and 0.8 mm,between approximately 0.3 mm and approximately 0.7 mm, or betweenapproximately 0.4 mm and approximately 0.6 mm. In addition, in certainimplementations, the protruding anchor members 105 may conform tocertain aspect ratios between the wall thickness WT to the strut widthSW. For example, and without limitation, protruding anchor members 105according to certain embodiments may have an aspect between 4:0.5 and1:2, between 3:1 and 1:1.2, or between 2:1 and 1:1. In certainembodiments, the cross-sectional radios of curvature CSR may be betweenapproximately 2 mm and approximately 6 mm, between approximately 3 mmand approximately 5 mm, or between approximately 3.5 mm andapproximately 5 mm. Each protruding anchor member 105 has a wallthickness WT of approximately 0.46 mm, an aspect ratio of approximately2:1 (resulting in a strut width SW of approximately 0.23 mm), across-sectional radius of curvature CSR of approximately 5 mm, and alength of approximately 1.5 mm. In certain embodiments of the presentdisclosure, each of the protruding anchor members 105 may bedimensionally identical; however, in other embodiments, one or more ofthe protruding anchor members 105 may differ in any of the variouscharacteristics noted above.

In one embodiment, as can be understood from FIGS. 2, 3 and 5 , theprotruding anchor members or barbs 105 are oriented distally andradially outward. As a result, as the frame 55 is pushed towards theventricle, the anchor members 105 slide along the atrial tissue.Ventricular pressure pushes the implant 20 towards the atrium, embeddingthe anchors or barbs 105 into the atrial tissue.

In an alternate embodiment, the anchors or barbs 105 are directionallyreversed such that they project distally and radially inward. In thisalternative embodiment, the delivery system over-expands the frame 55during delivery and when the frame is released from the delivery systemwith the frame 55 in contact with tissue, the anchors or barbs 105engage the atrial tissue as the frame 55 contracts to its relaxed state.

II. Delivery Tool and Method of Implantation

As illustrated in FIGS. 1A-1D, the delivery tool 15 includes a proximalend 30, a distal end 25 opposite the proximal end, a control handle 35,a tubular sheath 76, and a catheter 77. The control handle 35 extendsdistally from the proximal end 30 and is used by a physician tomanipulate the tool 15 in positioning the implant 20 at the target siteand deploying the implant 20 within the target cardiac valve in need ofrepair. The sheath 76 and catheter 77 extend distally away from thecontrol handle 35 towards the distal end 25 of the tool 15. The catheter77 extends longitudinally through the sheath 76, the distal end 25 ofthe catheter 77 forming the distal end 25 of the tool 15. The sheath 76is used to minimize tissue trauma while the catheter 77 and implant 20are advanced to the implantation site. Thus, the delivery tool 15 isdesigned to deliver the implant 20 to the implantation site, positionthe implant in the target cardiac valve, and control the opening of theframe 55 of the implant 20, all in an atraumatic manner.

As depicted in FIG. 8 , which is an enlarged view of the distal regionof the cardiac repair system 10 of FIG. 1A, sutures 130 extend between adistal region of the catheter 77 and points of connection on the frame55 of the implant 20. The sutures 130 further extend from the distalregion of the catheter up into the handle 35 and, in one embodiment, mayeven extend out of the handle, as shown in FIG. 1A. Depending on theembodiment, the control sutures 130 could be replaced by cables or wire.

As can be understood from FIGS. 1A and 8 , before the implant 20 iscompletely freed of the delivery tool 15, the sutures 130 can bemanipulated via the handle 35 of the tool 15 to control the opening ofthe implant frame 55. Suture actuation may have one or two speeds, whichmay be in the form of a slow speed and/or a fast speed. The slower speedmay be controlled by a spooling mechanism or a lead screw mechanism 135within the handle. The fast speed may be controlled by a plunger stylelinear actuator 140 within the handle. The sutures 130 may be routedwithin the handle 35 to provide a 2-to-1 mechanical advantage tofacilitate increased precision of control when deploying the implant 20.

The catheter 77 may employ steering via selective actuation (e.g.,tension increase/decrease) of certain sutures to better control theposition of the implant during deployment. This steering feature may becontrolled at the handle 35.

FIG. 9 is a side cross-sectional elevation view of the sheath 76 of thedelivery tool 15 with the implantable cardiac valve repair implant 20and distal region of the catheter 77 located therein. As can beunderstood from FIG. 9 , during delivery the implant 20 is maintained inthe collapsed state by being confined within the sheath 76, and theimplant 20 is coupled to a distal end of a catheter 77 that extendsthrough the sheath 76. The control sutures 130, while not shown in FIG.9 for clarity purposes, would extend through the catheter 77 and/or thesheath 76, as can be understood from FIGS. 1A and 8 .

With the implant 20 maintained in the collapsed state by virtue of beingconfined within the sheath 76 of the delivery tool 15, the implant maybe delivered and deployed at the target site via an antegradepercutaneous route (e.g., a trans-femoral or trans-jugular route) withthe patient consciously sedated during the procedure. A distal end 25 ofthe catheter 77 is coupled with the proximal end 65 of the centraloccluder 50 to maintain the implant 20 within the sheath 76 in thecollapsed state until the physician decides to deploy the implant withinthe target cardiac valve.

Upon the implant being properly positioned in the atrium and beginningto approach the target cardiac valve for repair, the physician actuatesthe tool 15 to cause the catheter 77 to act as a plunger and/or stopper,thereby driving the collapsed implant 20 distally from the confines ofthe sheath 76 and/or allowing the sheath 76 to be withdrawn proximallyfrom about the implant 20. Upon the collapsed implant 20 becomingexposed by action of exiting the distal end 129 of the sheath, theimplant 20 self-biases into its expanded state, as depicted in FIGS. 2-6. However, as indicated in FIG. 8 , despite having exited the sheathdistal end 129 and assuming the expanded state, the proximal end 65 ofthe central occluder 50 of the implant 20 remains coupled to thecatheter distal end 25 and the implant frame 55 is coupled to thesutures 130, thereby allowing the physician to use the delivery tool 15to drive the implant into the target valve and manipulate the implanttherein for implantation.

The configuration of the implant 20 facilitates delivery andimplantation that is very easy and fast. The implant’s ease of deliveryis facilitated by it generally only requiring the user to approximatelycenter the frame and push it into the valve.

Upon arrival of the implant 20 within the atrium and at the targetcardiac valve, the physician simply uses the tool 15 to actuate thesutures 130 to allow the frame 55 to self-bias open over the atrial sideof the target cardiac valve in a controlled manner. The catheter 77 ofthe tool 15 is then used to push the implant 20 towards the ventricle toengage the frame barbs 105 into the atrial tissue surrounding the targetcardiac valve. The control sutures 130 can be used to collapse the frame55 of the implant 20 to facilitate repositioning of the implant ifnecessary. Once the implant is fully implanted as desired by thephysician, the exposed ends of the control sutures 130 are cut neartheir points of securement to the implant frame 55, and the catheterdistal end 25 is released (e.g., unscrewed or otherwise decoupled) fromthe proximal end 65 of the central occluder 50. With the tool 15 sodecoupled from the implanted implant, the tool can be withdrawn from thepatient.

FIG. 10 is a view of the implant 20 implanted in a target cardiac valve,as viewed from an atrial position looking towards the valve and theventricle chamber below. As depicted in FIG. 10 , upon being implantedin the target cardiac valve, the implant anchors itself within thetarget cardiac valve and is configured to reduce regurgitation in thetarget cardiac valve. When implanted, the implant 20 is located on theatrial side of the target cardiac valve. The frame engages the atrialtissue via the small barbs 105. The thin sheet 60, which is supported onthe frame 55, forms an annular surface 62 supported on the expandedframe 55. This annular surface 62 extends across the atrial tissuecircumferentially around the circumference of the target cardiac valve.The central occluder 50 is suspended off the frame 55 and located in themiddle of the valve orifice or opening. So positioned, the implantprovides the following advantages and reduces regurgitation throughmultiple mechanisms-of-action.

First, the metal frame 55 supports a central occluder 50 that ispositioned to block a central leak in the target cardiac valve, thecentral occluder thereby reducing central regurgitation through thetarget cardiac valve. Specifically, the central occluder may block partor all of the central regurgitation in the valve.

Second, the thin sheet 60 covering the frame 55 encourages ingrowth withthe atrial and annular tissue surrounding the target cardiac valve. Withsuch tissue ingrowth, the thin sheet and its supporting frame 55 can actas an annuloplasty ring to buttress the native tissue and reducemyocardial stretching that could increase regurgitation.

Third, the thin sheet 60 covering the frame 55 may overlap the edges ofthe leaflet commissures, reducing the possibility of commissural leak.

Finally, the frame 55 may be over-expanded before engaging the retentionbarbs 105 in the tissue. When the frame is allowed to relax, the frame55 may reduce the valve orifice of the target cardiac valve and improveapposition of the valve leaflets, thereby reducing or eliminatingregurgitation.

III. Steerable Delivery Tool

FIGS. 11A and 11B are plan and side elevation views, respectively, of analternative valve repair system 1100 according to the presentdisclosure. Similar to valve repair systems previously discussed herein,the valve repair system 1100 is generally configured to deliver anddeploy an implant 20 at a target site, which is generally in a cardiacvalve requiring repair. Embodiments of the valve repair system 1100 maybe used with, but are not limited to being used with, any implantsdiscussed herein or that are otherwise consistent with this disclosure.

As shown in FIGS. 11A and 11B, the valve repair system 1100 includes adelivery tool 1115. The tool 1115 includes a proximal end 1130 oppositea tool distal end 1125. The delivery tool 1115 further includes atubular sheath 1176, and a catheter 1177. A control handle 1135 extendsdistally from the proximal end 1130 and is used by a physician tomanipulate the tool 1115 in positioning the implant 20 at the targetsite and deploying the implant 20 within the target cardiac valve inneed of repair. The sheath 1176 and catheter 1177 extend distally awayfrom the control handle 1135 towards the distal end 1125 of the tool1115. The catheter 1177 extends longitudinally through the sheath 1176,the distal end 1125 of the catheter 1177 forming the distal end 1125 ofthe tool 1115. The sheath 1176 is used to minimize tissue trauma whilethe catheter 1177 and implant 20 are advanced to the implantation site.Thus, the delivery tool 1115 is designed to deliver the implant 20 tothe implantation site, position the implant in the target cardiac valve,and control opening of the implant 20, all in an atraumatic manner.

To facilitate delivery of the implant 20 to the implantation site, thecatheter 1177 of the tool 1115 may be steerable. In the specificimplementation illustrated in FIGS. 11A and 11B, for example, thecontrol handle 1135 of the tool 1115 includes a bidirectional steeringcontrol 1180 that may be rotated to steer the distal end 1125 of thetool 1115. As illustrated in FIG. 11C, the steering control 1180 may berotatable between two extents, illustrated by dashed outlines 1190A,1190B, to steer the distal end 1125 between corresponding extents,illustrated by dashed outlines 1192A, 1192B. In the specific exampleillustrated, the steering control 1180 facilitates steering of thedistal end 1125 across a range of motion of approximately 180 degrees.Stated differently, the steering control 1180 may rotate the distal end1125 between a first position in which the distal end 1125 points in afirst lateral direction and a second position in which the distal endpoints in a second lateral direction that is opposite the first lateraldirection.

In certain embodiments, steering of the distal end 1125 is achieved bycoupling the steering control 1180 to a steering segment 1182 disposedalong the catheter 1177, distal the steering control 1180. Morespecifically, the steering control 1180 may include lateral members1184A, 1184B, each of which is coupled to a respective side of a distalend of the steering segment 1182 by respective pull wires 1186A, 1186B.Accordingly, when the steering control 1180 is rotated, thecorresponding pull wire is pulled and the steering segment 1182 is madeto bend in the same direction. For example, referring to FIG. 11C, whenthe steering control 1180 is rotated counterclockwise with respect tothe view of FIG. 11C, as illustrated by dashed outline 1190A, thelateral member 1184A pulls the pull wire 1186A, resulting in the distalend 1125 curling in a counterclockwise direction, as illustrated bydashed outline 1192A. Similarly, when the steering control 1180 isrotated clockwise with respect to the view of FIG. 11C, as illustratedby dashed outline 1190B, the lateral member 1184B pulls the pull wire1186B, resulting in the distal end 1125 curling in a clockwisedirection, as illustrated by dashed outline 1192B.

The steering segment 1182 may take various forms; but, in general, is aflexible and manipulable segment of the catheter 1177 or a separatesleeve or sheath coupled to the catheter 1177. In certain embodiments,for example, the steering segment 1182 may be a sleeve or a portion ofthe catheter 1177 that is formed from a flexible material. In otherembodiments, the steering segment 1182 may be segmented or otherwiseinclude slits, cutouts, or similar voids along its length to provideflexibility. In one specific implementation, the steering segment 1182may have a helical shape. In still other embodiments, the steeringsegment 1182 may be have a segment of the catheter 1177 having a reducedwall thickness. The foregoing are merely examples and other techniquesfor forming the steering segment 1182 that may be used are contemplated.

In certain embodiments, the pull wires 1186A, 1186B are run within anannular space defined between the sheath 1176 and the catheter 1177.Alternatively, the pull wires 1186A, 1186B may be run through a lumendefined within a wall of the catheter 1177, a wall of the sheath 1176,or a third annular body disposed along the distal length of the tool1115. For example, the catheter 1177 or an additional tubular sheathdisposed between the catheter 1177 and the sheath 1176 may be formed asa triple lumen extrusion including a central lumen and a pair of smallerlumens disposed on opposite sides of the central lumen and through whichthe pull wires 1186A, 1186B extend.

Although illustrated in FIG. 11C as having a 180-degree range of motion,embodiments of the present disclosure may be configured to have otherranges of motions. For example, certain embodiments may be configured torotate the distal end 1125 through 360 degrees of rotation, e.g., from afirst position in which the distal end 1125 points proximally on a firstside of the tool 1115 to a second position in which the distal end 1125also points proximally on a second side of the tool 1115 opposite thefirst side. In other embodiments, the distal end 1125 may have a reducedrange of motion such as but not limited to 135 degrees, 90 degrees, 45degrees, or 15 degrees. In addition, while the range of motionillustrated in FIG. 11C is illustrated as being substantially even inboth directions, embodiments of the present disclosure may have rangesof motion that are uneven in different directions. For example, a toolwith a 135-degree range of motion may travel 90 degrees in a firstdirection but only 45 degrees in a second direction opposite the firstdirection. Moreover, while the tool 1115 has a neutral position in whichthe catheter 1177 is substantially straight, the catheter 1177 mayalternatively be configured to have a bias in a particular direction.

IV. Implant With Tension Control Line

FIG. 12 is a distal plan view of the implant 20 in an expanded state andincorporating a tension control line 200. As previously discussed in thecontext of FIGS. 2-6 , the implant 20 generally includes a centraloccluder 50, a frame 55 and a thin sheet 60 supported on the frame 55.Further details regarding the components and construction of the implant20 and the frame 55 are provided above in the context of FIGS. 2-6 .

As illustrated in FIG. 12 , the tension control line 200 may be in theform of a wire, suture, cord, or similar elongate body coupled to theframe 55 and radially inward of the thin sheet 60 relative to thelongitudinal axis 70 (shown in FIG. 5 ) of the implant 20. The tensioncontrol line 200 may form a loop extending around the frame 55 and maybe formed from a single length of wire, suture, etc. In otherimplementations, the tension control line 200 may instead be formed frommultiple discrete segments of wire, suture, etc., with each discretesegment coupled to the frame 55 and optionally coupled to adjacentsegments of the control line 200.

During operation and, more specifically, during deployment of theimplant 20, the tension control line 200 is releasably coupled totension control members (e.g., tension control members 320 illustratedin FIGS. 13-22 and discussed below in further detail) of a delivery tool(e.g., delivery tool 300, similarly illustrated in FIGS. 13-22 anddiscussed below). The tension control members may be coupled to a handleor similar actuatable component of the delivery tool (such as the handle35 of the tool 15 previously discussed), to vary tension applied to thetension control line 200 by the tension control members. For example,rotating the handle 35 in a first direction may cause the tensioncontrol members to translate proximally/retract, thereby increasingtension on the tension control line 200, while rotating the handle 35 inan opposite direction may cause the tension control members to translatedistally/extend, thereby reducing tension on the tension control line200. Stated differently, manipulating the handle 35 in a first directiongenerally stops expansion of and/or collapses the frame 55 of theimplant 20 (e.g., to allow repositioning of the implant 20) whilemanipulating the handle 35 in a second direction generally stopscollapse of the frame and/or expands the frame 55, whether by action ofthe handle 35 or as a result of a bias of the frame 55 to into theexpanded configuration.

In general, the tension control line 200 is releasably retained by thetension control members at discrete locations along the length of thetension control line 200. The tension control line 200, however, extendsacross the frame 55 and is coupled to the frame 55 at multiplelocations. As a result, even though tension modifications may be appliedat the connection point between the tension control members and thetension control line 200, tension is distributed relatively evenlyacross the tension control line 200 and the frame 55, thereby providingeven expansion and collapse of the frame 55 and improved control duringdeployment and placement of the implant 20.

In the implementation of FIG. 12 , the tension control line 200 iscoupled to (e.g., tied or adhered to) the inner arcuate members 115 ofthe frame 55. More generally, the tension control line 200 may becoupled to any suitable portion of the frame 55 such that the tensioncontrol line 200 substantially extends about the frame 55. For example,and without limitation, in other implementations of the presentdisclosure, the tension control line 200 may instead be fixed to spokes95, outer arcuate members 110, or any other suitable portion of thepetal portions 100 of the frame 55.

In certain implementations, the tension control line 200 may beadditionally coupled to other locations of the frame 55 by additionalcontrol segments or linking structures. For example, FIG. 12 illustratesthe tension control line 200 coupled to the inner arcuate members 115 ofthe frame 55. The tension control line 200 is further coupled to each ofthe outer arcuate members 110 by corresponding links, such as the link202. Similar to the control line 200, the link 202 may be formed ofwire, suture, or similar material and, in certain cases, may be formedof the same material as the control line 200. In operation, the link 202helps to further distribute tension to the outer arcuate members 110and, as a result, further improves control of expansion an collapse ofthe frame during deployment of the implant 20.

Although illustrated in FIG. 12 as coupling the tension control line 200to the outer arcuate members 110, in other implementations, links may beused to couple the tension control line 200 to other elements of theframe 55 depending on how the tension control line 200 is configured.For example, in implementations in which the tension control line 200 iscoupled to the outer arcuate members 110, links may be used to couplethe tension control line 200 to the inner arcuate members 115.

V. Deployment of Implants With Tension Control Lines

As previously discussed, implants according to the present disclosuremay include tension control lines for enhanced control during deploymentand implantation. Such delivery and implantation may be furtherfacilitated by corresponding delivery tools configured to modify andcontrol tension applied to the tension control lines and to selectivelyrelease the implant when properly positioned.

FIG. 13 is a photograph including a delivery tool 300 in accordance withthe present disclosure in a disassembled state. As illustrated, thedelivery tool 300 generally includes a sheath 302, a release catheter304, and a tension control assembly 306. An implant 20 including atension control line 200 is also pictured. The sheath 302 generallyforms an exterior of the delivery tool 300 and houses the othercomponents during insertion into the patient. More specifically, therelease catheter 304 is generally disposed within the sheath 302 and thetension control assembly 306 is, in turn, disposed within the releasecatheter 304.

As described below in further detail, the tension control line 200 ofthe implant 20 is releasably coupled to the tension control assembly 306by the release catheter 304 and is maintained in a collapsed statewithin the sheath 302 during initial insertion into the patient. Duringdeployment, the release catheter 304 is distally extended from thesheath 302, thereby allowing the implant 20 to expand. Subsequentcontrol of expansion and collapse of the implant 20 is facilitate bytension control members 320 extending from the tension control assembly306, which are coupled to the tension control line 200 of the implant 20by release lines 350 of the release catheter 304. Following location ofthe implant 20 within the patient, the release lines 350 are retractedto decouple the tension control members 320 from the tension controlline 200, thereby releasing the implant 20.

FIG. 14 is a cross-sectional view of a distal portion 301 of thedelivery tool 300 in an assembled state and with each of the releasecatheter 304 and the tension control assembly 306 in an extendedconfiguration for purposes of illustrating various elements of thedelivery tool 300. FIG. 15 is also a cross-sectional view of the distalportion 301 of the delivery tool 300 but further includes an implant 20and illustrates the delivery tool 300 in a retracted state, such aswould be the case during initial insertion of the delivery tool 300 intothe patient. For purpose of illustrating coupling of the implant to therelease catheter 304, the frame 55 and associated components of theimplant 20 are only partially illustrated in FIG. 15 .

As previously discussed, tension control assembly 306 generally includestension control members 320 that are releasably coupled to the controlline 200 of the implant 20. As illustrated in FIGS. 14 and 15 , thetension control members 320 may be in the form of cables, controlsutures, wires, or similar elongate structures that extend distally froma distal end of a tension control shaft 324. In at least certainimplementations, the tension control members 320 may terminate in a loop(e.g., loop 322) or similar structure to facilitate coupling to thetension control members 320 to the tension control line 200 of theimplant 20. FIG. 19 is a photograph of the tension control assembly 306disposed within the release catheter 304 with the tension controlmembers 320 extending distally out of a catheter body 352 of the releasecatheter 304.

The release catheter 304 includes release lines 350 disposed within andextending through the catheter body 352. The catheter body 352 furtherdefines two sets of lateral holes for facilitating tensioning andrelease functionality of the delivery tool 300. More specifically, thecatheter body 352 defines a set of proximal holes 360 and a set ofdistal holes 362. The catheter body 352 further defines a distal opening357. As illustrated in FIGS. 14 and 19 , the tension control assembly306 is generally assembled with the release catheter 304 such that thetension control members 320 extend distally through the proximal holes360.

The implant 20 is generally coupled to the delivery tool 300 by couplingthe implant 20 to the tension control members 320 using the releaselines 350. FIG. 16 is a photograph of a proximal perspective view of theimplant 20 coupled to the delivery tool 300 in an expanded state toillustrate such coupling. As illustrated in Detail B of FIG. 16 , a loop201 of the tension control line 200 is pulled through the loop 322 ofthe tension control member 320. The release line 350 is then passedthrough the loop 201 of the tension control line 200 and across the loop322 of the tension control member 320, thereby retaining the loop 201 ofthe tension control line 200 through the loop 322 of the tension controlmember 320. To release the coupling between the control line 200 and thetension control member 320, the release line 350 is slid out of the loop201, thereby enabling the loop 201 to pass through the loop 322 of thetension control member 320 and decoupling the tension control member 320from the control line 200. Detailed photographs of the loop 201 of thetension control line 200 coupled to the loop 322 of the tension controlmember 320 are provided in FIGS. 17 and 18 .

Referring back to FIG. 15 , routing of the release lines 350 generallyincludes routing the release lines 350 (shown in dashed lines forclarity and distinction over other illustrated elements) through thecatheter body 352 to an exterior thereof, such as by passing the releaselines 350 through the distal holes 362 of the catheter body 352. Therelease lines 350 may then be routed proximally to join the control line200 to the tension control members 320, as noted above and asillustrated in FIGS. 16-18 . The release lines 350 may then be routedproximally and back into the catheter body 352 through the proximalholes 360 where the release lines 350 may be retained, e.g., byfriction, until the implant 20 is to be released.

As shown in FIG. 15 , in at least certain implementations, the occluder50 of the implant 20 may include a proximally extending annularprotrusion 51 defining each of a proximally open annulus 53 andlaterally extending holes 57 in communication with the annulus 53. Insuch implementations, the annular protrusion 51 may be disposed withinthe distal opening 357 (shown in FIG. 14 ) of the release catheter 304during insertion and delivery to an implantation location and therelease lines 350 may be further routed into the annulus 53 and throughthe holes 57 before being passed through the distal holes 362 of thecatheter body 352.

FIGS. 20-22 illustrate the general process of releasing the implant 20from the delivery tool 300. Referring first to FIG. 20 , the deliverytool 300 and implant 20 are shown with the frame 55 of the implant 20 inan expanded configuration but still coupled to the delivery tool 300.More specifically, the implant 20 is coupled to the delivery tool 300 byvirtue of the release lines 350 of the release catheter 304, each ofwhich is routed, in order, through the catheter body 352, through theannular protrusion 51 of the implant 20, through one of the distal holes362 of the catheter body 352, through one of the loops 201 of thetension control line 200 extending through a loop 321 of one of thetension control members 320, and back into the catheter body 352 throughone of the proximal holes 360. As previously noted, in at least certainimplementations, the ends 356 of the release lines 350 may be retainedwithin the catheter body 352 by friction.

In the state illustrated in FIG. 20 , the tension control shaft 324 ofthe tension control assembly 306 may be actuated (e.g., by translatingand/or rotating the shaft or a handle assembly coupled to the shaft) tovary the tension applied to the frame 55 of the implant 20. By doing so,the frame 55 may be expanded and/or collapsed to facilitate placement ofthe implant 20 prior to release of the implant 20 from the delivery tool300.

Referring next to FIG. 21 , the delivery tool 300 and implant 20 areillustrated part way through release of the implant 20 from the deliverytool 300. In general, release of the implant 20 from the delivery tool300 is performed by pulling the release lines 350 proximally through thecatheter body 352. As illustrated and for each release line 350 and asindicated by the open arrows, such pulling causes the end 356 of therelease line 350 to exit the catheter body 352 through one of theproximal holes 360, pass through one of the loops 201 of the tensioncontrol line 200 to release the loop 201 from a corresponding controlmember 320, pass through one of the distal holes 362 of the catheterbody 352 and the annular protrusion 51 of the implant 20, and reenterthe catheter body 352 through the distal opening 357 of the catheterbody 352. As a result, pulling the release lines 350 decouples theimplant from the delivery tool and allows removal of the delivery tool300 with the implant 20 remaining in place, as shown in FIG. 22 .Following release of the implant 20, each of the release catheter 304and the tension control assembly 306 may be proximally retracted and/orproximally removed from the sheath 302.

Notably, the process of releasing the implant 20 from the delivery tool300 by pulling the release lines 350 applies a net force on the implant20 that expands the frame 55 and/or resists collapse of the frame 55.More specifically, as the release lines 350 are pulled to release theimplant 20, the release lines 350 apply a net distal force on theimplant 20, thereby pressing the implant 20 into its currentimplantation location. Moreover, because such distal force is applied atthe connection between the control line 200 and the tension controlmember 320 it acts to further expand or otherwise provide additionalcounterforce against collapse of the frame 55. In contrast, if a netproximal force were to be applied, the implant 20 may be pulled out ofplace and/or the frame 55 may undergo a partial collapse, eachpotentially leading to the implant 20 becoming dislodged or losing itsorientation. Accordingly, by routing the release lines 350 as notedabove, proper placement of the implant 20 is more easily controlled andmore likely to be maintained following release of the implant 20.

VI. Multi-Part Occluder

FIGS. 23 and 24 illustrate a distal portion of an example implant 400that may be used in implementations of the present disclosure. Morespecifically, FIG. 23 is a side elevation view of the distal portion ofthe implant 400 while FIG. 24 is a cross-sectional view of the implant400, each of which emphasize an occluder 401 of the implant 400.

As illustrated, the occluder 401 includes an occluder body 402 defininga cavity 403 within which an insert 404 is disposed. The insert 404 iscoupled to the occluder body 402. In the specific implementationillustrated in FIGS. 23 and 24 , the insert 404 is coupled to theoccluder body 402 by a threaded connection 406; however, any suitableconnection (e.g., adhesive, welding, etc.) may be used instead of athreaded connection.

The occluder 401 further includes a frame base 408 disposed within thecavity 403 of the occluder body 402 and distal the insert 404. The framebase 408 is coupled to a frame 455 of the implant 400 (shown in part andwhich may be substantially similar to other frames disclosed herein)which extends from the frame base 408 and exits proximally from theoccluder body 402. The frame base 408 may be coupled to the occluderbody 402 and/or may be maintained in place by the insert 404.

The insert 404 further includes a proximally extending annularprotrusion 410. The annular protrusion 410 includes a sidewall 412through which one or more laterally extending holes 414 may be defined.As previously discussed in the context of FIGS. 15 and 20-22 , duringuse of systems disclosed herein, release lines of a delivery tool may berouted through the holes 414 to secure the implant 400 to a deliverytool and, more specifically, to a release catheter of a delivery tool.

The occluder 401 further includes a marker 416 disposed within theoccluder body 402. In certain implementations, the marker 416 may be aradiopaque marker to facilitate fluoroscopic observation of the implant400 during delivery and implantation. As shown, the marker 416 may beembedded within the occluder body 402, such as by molding the occluderbody 402 about the marker 416. In other implementations, the cavity 403may be shaped to receive the marker 416 in addition to the insert 404and the frame base 408. In still other implementations, the marker 416may be disposed on an exterior surface of the occluder body 402.Although illustrated as a spherical bead in FIG. 24 , the marker 416 maybe have any suitable shape. Similarly, any suitable number of markersmay be incorporated into the occluder body 402. In otherimplementations, the occluder body 402 may be formed from a materialwith radiopaque additives. In still other implementations, either orboth of the frame base 408 and the insert 404 may be formed ofradiopaque material or include one or more radiopaque markers.

VII. Skirted and Sheet-Based Occlusive Assemblies

As noted above, implementations of implants according to the presentdisclosure may include an occlusive body supported by a frame with athin sheet supported by and extending around a proximal portion of theframe. When the implant is deployed within the heart to support functionof a heart valve, the frame is supported by an annulus of the valve orby the walls of the atrium such that the occlusive body is disposed tointeract with and seal against leaflets of the valve. In certainimplementations, the thin sheet may be formed from a material thatallows for tissue ingrowth such that, over time, the implant is retainedmore robustly within the heart. In addition to this structural function,the thin sheet may be configured to at least partially overlap one ormore commissures of the valve leaflets to correct or reduce commissuralregurgitation.

In addition to the outer thin sheet discussed above, implementations ofthis disclosure may alternatively or additionally include an innersheet. For example, implants of the present disclosure may include anocclusive assembly that includes an occlusive body (such as thebullnose-style occluder or other occluders discussed above) and a sheetof material (generally referred to as a “skirt” or “inner sheet” herein)that extends from and circumferentially around the occlusive body. Insuch implementations, the inner sheet may be coupled to the occlusivebody and/or portions of the implant frame extending from the occlusivebody. In other implementations, the occlusive assembly may omit anocclusive body such that the inner sheet forms a cap-like structure on adistal end of the implant supported by and coupled to a distal portionof the frame. In such implants, the inner sheet may provide a sealingsurface for the valve leaflets similar to that provided by the occlusivebody. Like the outer sheet, the inner sheet may be formed of a materialthat promotes or allows tissue ingrowth to create a smooth layer ofbiological cells. The layer of biological cells may provide a barrierbetween the inner sheet and native valve leaflets to prevents wearingeffects between the inner sheet and native valve leaflets.Alternatively, the inner sheet may be formed from a low frictionmaterial (such as PTFE or ePTFE) that resists cell in-growth to providea smooth surface that prevents wearing effects between the inner sheetand native valve leaflets.

In certain implementations, either of the outer and inner sheets mayhave a multi-layered construction in which an internal pocket is definedbetween layers of sheet material. The pocket may contain an additionallayer of fabric to serve as padding (e.g., a layer of PET, ePTFE, orother fabric). The pocket may also or alternatively contain awater-absorbing material, such as a hydrogel (e.g., sodium polyacrylateor polyvinyl alcohol) that expands following implantation. In any of theforegoing cases, the filling may form a pad. In implementations in whichthe inner sheet is formed to include an absorbing/expanding pocket, suchpockets may generally pad or otherwise increase the distance between theoccluding surface/sheet and the underlying frame of the implant, therebypreventing and padding contact between valve leaflets and the frame.

The foregoing aspects of this disclosure and related concepts are nowdiscussed in further detail with reference to the figures.

FIGS. 25 and 26 illustrate an example of an implant 2500 including askirted occlusive assembly. Specifically, FIG. 25 is a perspectivedistal-side view of implant 2500 while FIG. 26 is a perspectiveproximal-side view of implant 2500. FIGS. 25 and 26 illustrate implant2500 when implant 2500 is in an expanded state, such as exists whenimplant 2500 is implanted in a cardiac valve to be repaired. Asillustrated in FIG. 25 , implant 2500 includes a distal end 2540 and aproximal end 2545. Distal end 2540 serves as the leading end of implant2500 during implantation.

Implant 2500 includes an occlusive assembly 2502 that includes a centralocclusive body 2550 and an inner sheet 2552 extending about centralocclusive body 2550. Implant 2500 further includes a frame 2555 and anouter sheet 2560 supported on frame 2555. In the implementation of FIGS.25 and 26 , frame 2555 extends proximally from central occlusive body2550. When in the expanded state, the frame 2555 radiates laterallyoutwardly relative to a central longitudinal axis 2570 of implant 2500.In the expanded state, inner sheet 2552 forms a first annular surface2561 and outer sheet 2560 forms a second annular surface 2564, each ofwhich is supported on frame 2555.

First annular surface 2561 has a proximal radially outward edge 2563.Similarly, second annular surface 2564 has a distal radially inward edge2565 and a proximal radially outward edge 2566. Proximal radiallyoutward edge 2563 of first annular surface 2561 and distal radiallyinward edge 2565 of second annular surface 2564 define a central opening2567 between inner sheet 2552 and outer sheet 2560. Proximal radiallyoutward edge 2566 of outer sheet 2560 may form the extreme proximalradially outward boundary of the implant when in the expanded state;however, as shown in FIGS. 25 and 26 , at least a portion of frame 2555may extend beyond proximal radially outward edge 2566 of outer sheet2560. Central longitudinal axis 2570 passes through the extreme distaltip 2575 of central occlusive body 2550. Considering the foregoing andin at least certain embodiments, frame 2555 is generally designed to siton the floor of the atrium, to induce annular reduction, and to producea neo-annulus.

In addition to being annular, either of first annular surface 2561 andsecond annular surface 2564 may also be conical, or relatively so (e.g.,parabolic).

When implant 2500 is in the collapsed state, e.g., during delivery ofimplant 2500 to the target site via a corresponding tool (e.g., the tool15 of FIG. 1A), frame 2555, inner sheet 2552, and outer sheet 2560collapse symmetrically about the central longitudinal axis 2570. Thus,like implant 20 of FIGS. 2-6 , implant 2500 can transition from thecollapsed state to the expanded state like an umbrella. For example andas previously discussed herein in the context of implant 20, implant2500 may be maintained in a collapsed state (similar to that illustratedin FIG. 7 for implant 20) by the tool 15 so as to allow implant 2500 tobe negotiated through the patient vascular system and into an atrialchamber of the heart for implantation of the implant within a targetcardiac valve. For example, with implant 2500 maintained in thecollapsed state by virtue of being confined within a tubular sheath 76of the delivery tool 15, implant 2500 may be delivered and deployed atthe target site via an antegrade percutaneous route (e.g., an antegradetrans-femoral or trans-jugular route) with the patient consciouslysedated during the procedure. Upon being properly positioned in thetarget cardiac valve for repair, the physician may actuate tool 15 suchthat tool 15 no longer maintains implant 2500 in the collapsed. Sinceframe 2555 of implant 2500 is biased to self-expand, implant 2500self-expands into the expanded state to anchor itself within the targetcardiac valve and reduce regurgitation.

Central occlusive body 2550 may take on various forms and shapes. Forexample, as previously discussed in the context of implant 20, centralocclusive body 2550 may have a bullet or conical shape. Additionaldetails regarding such shapes are provided above. Another alternativeshape for central occlusive body 2550 is a bulb and is illustrated inFIGS. 25 and 26 . In such implementations, central occlusive body 2550may include a distal bulb 2580 (shown in FIG. 25 ) with a cylindricalside 2585 (shown in FIG. 26 ) extending proximally therefrom. In certainimplementations, distal bulb 2580 may have a spherical shape; but mayalternatively have an ovoid or oblong shape. More generally, distal bulb2580 may have a shape selected to be atraumatic during delivery andimplantation purposes and that facilitates sealing of distal bulb 2580against the cardiac valve leaflets to reduce or even eliminate centralregurgitation past the cardiac valve leaflets.

In general, characteristics of central occlusive body 2550 may besimilar to those of central occluder 50 of implant 20. For example,central occlusive body 2550 may be formed various materials, includingangio- and/or echolucent materials, may be filled or fillable (e.g.,with saline) and may have properties and dimensional characteristicslike those of central occluder 50 discussed above.

Like thin sheet 60 of implant 20 being supported by frame 55, each ofinner sheet 2552 and outer sheet 2560 is supported on frame 2555 andsecured thereto. For example, and without limitation, inner sheet 2552and/or outer sheet 2560 may be secured to frame 2555 by suturing therespective sheet against an inner surface and/or an outer surface offrame 2555. In other implementations, inner sheet 2552 or outer sheet2560 may include a cuff or similar folded structure that is folded overan end of frame 2555. For example, as illustrated in FIG. 26 , innersheet 2552 is folded over and sutured against a distal frame portion2558. More specifically, distal frame portion 2558 includes acircumferential arrangement of arcuate petal portions (e.g., arcuatepetal portion 2557) extending distally from central occlusive body 2550.Inner sheet 2552 is then wrapped around a distal surface of distal frameportion 2558, folded over each arcuate petal portion 2557 and sutured inplace such that inner sheet 2552 is secured to distal frame portion2558.

Alternatively, each of inner sheet 2552 and outer sheet 2560 may besecured to frame 2555 by sewing, welding, gluing/adhering, stapling, orany other suitable securement method or combination of securementmethods. Inner sheet 2552 and/or outer sheet 2560 may be on the distalside of frame 2555, the proximal side of frame 2555, or both such thatthe frame extends through and along inner sheet 2552 and/or outer sheet2560. In at least one specific implementation, each of inner sheet 2552and outer sheet 2560 are supported on a distal side of frame 2555 suchthat, when implanted, outer sheet 2560 contacts the tissue of the atrialfloor while inner sheet 2552 is positioned to interact with and sealagainst the valve leaflets.

Depending on the particular implementation, inner sheet 2552 and/orouter sheet 2560 may be formed of or include a woven or knit material orfabric that encourages tissue ingrowth. Fabric for inner sheet 2552and/or outer sheet 2560 may generally have any of the properties orcharacteristics discussed above with respect to thin sheet 60 of implant20. Regarding outer sheet 2560, the porosity of the fabric may assist inreducing commissural tricuspid regurgitation. Further reduction ofcommissural tricuspid regurgitation may be provided by the angulation offrame 2555, which provides close contact between outer sheet 2560 andthe commissures in a circumferential manner. For example, with theimplant 2500 implanted in the target cardiac valve, tissue in-growthinto the fabric of outer sheet 2560 buttresses the myocardium, helpingto keep the tissue from expanding further and reducing the potential offuture regurgitation. Regarding inner sheet 2552, the porosity of thefabric may assist in reducing central regurgitation by providing anexpanded surface relative to central occlusive body 2550 alone againstwhich the valve leaflets may seal. In at least certain implementations,inner sheet 2552 may be formed from PTFE, ePTFE, or a similarlow-friction polymer to provide a smooth surface for the native leafletsto abut against.

Frame 2555 may include spokes 2595 from which various arcuate petalportions extend. For example, as discussed above, a distal portion offrame 2555 may include distal or inner arcuate petal portions, such asarcuate petal portion 2557, that support inner sheet 2552. Frame 2555may further include outer arcuate petal portions, such as arcuate petalportion 2559 configured to support outer sheet 2560. The outer arcuatepetal portions may be similar to or otherwise share characteristics andvariations of petal portions 100 of implant 20, which are describedabove in further detail.

Frame 2555 may be made from a variety of super-elastic and/or shapememory materials, including, for example, nickel-titanium alloys (e.g.,Nitinol), which may be laser cut from a tube or in the form of drawnwire. The features defined in the shape memory materials may be definedtherein via various cutting methods known in the art, include laser,water jet, electrical discharge machining (EDM), stamping, etching,milling, etc.

Like central occluder 50 and frame spokes or struts 95 of implant 20,occlusive assembly 2502 and spokes 2595 may be removable afterimplantation, leaving second annular surface 2564 formed by outer sheet2560 in place. In such embodiments, a circumferential suture connectionmay exist between spokes 2595 and the rest of frame 2555 radiallyoutward of spokes 2595. Thus, this circumferential suture connection maybe cut and occlusive assembly 2502 and spokes 2595 may be removedthrough a catheter, leaving the annular portion of the implant, whichthen acts as an “annuloplasty” frame.

Like spokes 95 of implant 20, spokes 2595 may proximally extend fromcentral occlusive body 2550 to the outer arcuate petal portions. Incertain implementations, spokes 2595 may extend substantially parallelwith, and extend along and near to, central longitudinal axis 2570 ofimplant 2500. When implant 2500 is in the expanded state, spokes 2595proximally extend from central occlusive body 2550 and laterally radiateaway from central longitudinal axis 2570 to the outer arcuate petalportions. In general, spokes 2595 may be configured similar to and havecharacteristics to spokes of other frame embodiments discussed herein.For example, the dimensional characteristics and variations providedabove with respect to frame 55 (and elements thereof) of implant 20 maybe similarly applicable to frame 2555 and its components.

Outer arcuate petal portions, such as arcuate petal portion 2559 may besimilar to petal portions 100 of implant 20, discussed above. Innerarcuate petal portions, such as arcuate petal portion 2557, may belocated between a pair of spokes 2595. When in the expanded state, theinner arcuate petal portions may be straight or curved in a laterallyradiating direction. In certain implementations, when curved, the radiusof curvature of the inner arcuate petal portions may be like that ofspokes 2595 or may differ from that of spokes 2595. Although illustratedas including only singular arcuate members, each inner arcuate petalportion 2557 may instead include multiple arcuate members, such as theinner and outer arcuate members of petal portions 100.

In different implementations, frame 2555 may include different numbersof inner arcuate petal portions. For example, in certain exampleembodiments, frame 2555 may include between 6 and 8, between 4 and 10,or between 2 and 12 inner acuate petal portions. In the specificimplementation illustrated in FIGS. 25 and 26 , for example, frame 2555includes 6 inner arcuate petal portions.

Like frame 55, frame 2555 may engage the atrial tissue via theprotruding anchor members 2597, which may be in the form of small barbs.Anchor members 2597 are designed to securely engage the atrial tissuewithout penetrating through the tissue or to the coronary vessels.Depending on the embodiment, the protruding anchor members or barbs 2597may be curved to slide before engaging tissue and there may be one ormore rows of protruding anchor members 2597. As shown in FIG. 25 , forexample, frame 2555 includes three offset rows of protruding anchormembers 2597 with a distal and intermediate row extending through outersheet 2560 and a proximal row projecting from a distal end of frame2555. Further details and alternative configurations provided above withrespect to protruding anchor members 105 are similarly applicable toanchor members 2597, including implementations in which 2597 aredirectionally reversed such that they project distally and radiallyinward.

FIGS. 27 and 28 illustrate another implant 2700 according to the presentdisclosure. Specifically, FIG. 27 is a perspective distal-side view ofimplant 2700 while FIG. 28 is a perspective proximal-side view ofimplant 2700. FIGS. 27 and 28 illustrate implant 2700 when implant 2700is in an expanded state, such as exists when implant 2700 is implantedin a cardiac valve to be repaired. As illustrated in FIGS. 27 and 28 ,implant 2700 includes a distal end 2740 (indicated in FIG. 27 ) and aproximal end 2745. Distal end 2740 serves as the leading end of implant2700 during implantation.

Implant 2700 includes an occlusive assembly 2702 disposed at distal end2740. In contrast to occlusive assembly 2502 of implant 2500, occlusiveassembly 2702 does not include an occlusive body. Rather, occlusion inocclusive assembly 2702 is provided entirely by an inner sheet 2752,which forms a cap-like structure disposed on distal end 2740. Likeimplant 2500, implant 2700 further includes a frame 2755 and an outersheet 2760, with each of inner sheet 2752 and outer sheet 2760 supportedon frame 2755. When in the expanded state, frame 2755 radiates laterallyoutwardly relative to a central longitudinal axis 2770 (indicated inFIG. 27 ) of implant 2500. In the expanded state, inner sheet 2752 formsa distal surface 2761 and outer sheet 2760 forms an annular surface2764, each of which is supported on frame 2755.

Distal surface 2761 has a proximal radially outward edge 2763 whileannular surface 2764 has a distal radially inward edge 2765 and aproximal radially outward edge 2766. Proximal radially outward edge 2763of distal surface 2761 and distal radially inward edge 2765 of annularsurface 2764 define a central opening 2767 between inner sheet 2752 andouter sheet 2760. Central longitudinal axis 2770 passes through anextreme distal tip 2775 of inner sheet 2752. Given the parabolic shapeof frame 2755, implant 2700 may be configured to traverse at leastpartially up the atrial walls. However, in other implementations, frame2755 may be configured such that implant 2700 is generally designed tosit on the floor of the atrium. In either case, implant 2700 maygenerally induce annular reduction and produce a neo-annulus.

Like implant 2500, implant 2700 may be transitioned into a collapsedstate, such as during delivery of implant 2700 to the target site. Whencollapsed, frame 2755, inner sheet 2752, and outer sheet 2760 maycollapse symmetrically about central longitudinal axis 2570. Thus, likeimplant 20 of FIGS. 2-6 and implant 2500, implant 2700 can transitionfrom the collapsed state to the expanded state like an umbrella. Also,like frame 55 of implant 20 and central occlusive body 2550 of implant2500, frame 2755 of implant 2700 may be biased to self-expand such thatimplant 2700 self-expands into the expanded state to anchor itselfwithin the target cardiac valve.

Each of inner sheet 2752 and outer sheet 2760 is supported on frame 2755and secured thereto using any suitable method. For example, and withoutlimitation, inner sheet 2752 and/or outer sheet 2760 may be secured toframe 2755 by suturing, sewing, welding, gluing/adhering, stapling, orany other suitable securement method or combination of securementmethods. In certain implementations, inner sheet 2752 or outer sheet2760 may include a cuff or similar folded structure that is folded overa portion of 2755. In the specific implementation illustrated in FIG. 28, inner sheet 2752 is sutured or otherwise coupled to a distal frameportion 2758 of frame 2755 without such a cuff or fold.

Like sheets previously discussed herein, inner sheet 2752 and/or outersheet 2760 may be on the distal side of frame 2755, the proximal side offrame 2755, or both such that the frame extends through and along innersheet 2752 and/or outer sheet 2760. In at least one specificimplementation, each of inner sheet 2752 and outer sheet 2760 aresupported on a distal side of frame 2755 such that, when implanted,outer sheet 2760 contacts the tissue of the atrial floor and/or atrialwall while inner sheet 2752 is positioned to interact with and sealagainst the valve leaflets. Like previous embodiments discussed herein,inner sheet 2752 and/or outer sheet 2760 may be formed of or include awoven or knit material or fabric that encourages tissue ingrowth toprovide the various advantageous discussed above.

Implementations of this disclosure are not limited to any sizes ordimensions and may be modified or customized to meet the needs ofpatients and specific applications. Nevertheless, in certainimplementations, proximal radially outward edge 2763 of inner sheet 2752may be from and including about 18 mm to and including about 28 mm. Forexample, in one specific implementation proximal radially outward edge2763 may be 23 mm. Similarly, distal radially inward edge 2765 may befrom and including about 35 mm to and including about 55 mm. Forexample, in one specific implementation, distal radially inward edge2765 may be 44 mm. Finally, proximal radially outward edge 2766 may befrom and including about 45 mm to and including about 65 mm. In onespecific example, proximal radially outward edge 2766 may be 55 mm.

While implant 20 and implant 2500 each included respective frames thatrelied primarily on a spoke-based design, frame 2755 illustrates anexample of a petal-based frame structure. Referring to FIG. 28 , frame2755 includes distal frame portion 2758, which supports inner sheet2752, and a proximal frame portion 2759, which supports outer sheet2760. In general, each of distal frame portion 2758 and proximal frameportion 2759 include a set of circumferentially distributed arcuatepetal portions configured to collapse and expand as implant 2700 issimilarly collapsed and expanded during delivery and implantation.

As shown in Detail C of FIG. 28 , distal frame portion 2758 may includearcuate petal portions that may be ovate, diamond-shaped, or that haveother elongate shape (e.g., generally diamond shaped albeit with roundedvertices or curved edges). Each such arcuate petal portion may bedefined by respective major and minor axes. For example, as shown inDetail C, arcuate petal portion 2780A may have a major axis 2781A thatextends in a substantially longitudinal direction and a minor axis 2782Athat extends in a circumferential direction. In certain implementations,adjacent arcuate petal portions may be joined at or near the verticesalong the minor axis, which are generally referred to as co-vertices.For example, and as indicated in FIG. 28 , arcuate petal portion 2780Aand arcuate petal portion 2780B are joined at a junction 2784 disposeddistal the co-vertices of arcuate petal portion 2780A and arcuate petalportion 2780B.

Proximal frame portion 2759 may similarly include arcuate petal portionsthat may be ovate, diamond-shaped, or have another elongate shape. Eachsuch arcuate petal portion may be defined by respective major and minoraxes. For example, arcuate petal portion 2785A may have a major axis2786A that extends in a substantially longitudinal direction and a minoraxis 2787A that extends in a circumferential direction. In certainimplementations, adjacent arcuate petal portions of proximal frameportion 2759 may be joined at or near the vertices along the minor axis(i.e., the co-vertices of the arcuate petal portions). For example,arcuate petal portion 2785A and arcuate petal portion 2785B are joinedat a junction 2789 disposed at the corresponding co-vertices of arcuatepetal portion 2785A and arcuate petal portion 2785B.

As further illustrated in FIG. 28 , arcuate petal portions of distalframe portion 2758 may be joined to respective arcuate petal portions ofproximal frame portion 2759. For example, arcuate petal portion 2780A iscoupled to arcuate petal portion 2785A by a longitudinal member 2790extending between a proximal vertex 2791 of arcuate petal portion 2780Aand a distal vertex 2792 of arcuate petal portion 2785A.

Like previous frames discussed herein, frame 2755 may be made from avariety of super-elastic and/or shape memory materials, including, forexample, nickel-titanium alloys (e.g., Nitinol), which may be laser cutfrom a tube or in the form of drawn wire. The features defined in theshape memory materials may be defined therein via various cuttingmethods known in the art, include laser, water jet, electrical dischargemachining (EDM), stamping, etching, milling, etc.

Depending on the embodiment, frame 2755 may include different numbers ofinner and/or outer arcuate petal portions. For example, in certainexample embodiments, frame 2755 may include between 10 and 14, between 8and 16, or between 6 and 18 inner and outer arcuate petal portions. Inthe specific implementation illustrated in FIGS. 27 and 28 , forexample, frame 2755 includes 12 each of inner and outer arcuate petalportions with each inner arcuate petal portion joined to a respectiveouter arcuate petal portion. In other implementations, the number ofinner arcuate petal portions may differ from the number of outer arcuatepetal portions. For example, frame 2755 may include twice as many innerarcuate petal portions as outer petal portions. Moreover, not everyinner arcuate petal portion may be joined to a corresponding outerarcuate petal portion or vice versa regardless of whether the number ofinner and outer arcuate petal portions matches. So, for example, in oneimplementation, an implant may include twice then number of innerarcuate petal portions as outer arcuate petal portions and every otherinner arcuate petal portion may be joined to an outer arcuate petalportion. In another implementation, the number of inner and outerarcuate petal portions may be the same; however, joining may still onlybe between every other inner and outer arcuate petal portion.

As shown in FIGS. 27 and 28 , each inner arcuate petal portion is unformas is each outer arcuate petal portion. In other implementations, theinner and outer arcuate petal portions may vary in any direction. Forexample, the inner arcuate petal portions may alternate between arcuatepetal portions having a first major axis dimension and arcuate petalportions have a second major axis dimension different than the firstmajor axis dimension.

Other examples of alternative frame configurations are discussed belowin the context of FIGS. 31-33 .

Although not illustrated in FIGS. 27 and 28 , frame 2755 may engageatrial tissue via protruding anchor members, like protruding anchormembers 105 of implant 20 or protruding anchor members 2597 or implant2500, discussed above.

VIII. Alternative Implant Frame Shapes

The overall shape of implants according to the present disclosure whenin the expanded state may vary across implementations to address variousneeds of a patient. Among other things, implant shape may be varied toaccommodate variations in patient anatomy and pathology. For example, incases where a patient may have weakened valves or valves exhibitingreduced travel, an implant configuration in which an occlusive assemblyis positioned deeper into the ventricle may be advantageous such thatcontact and sealing between the occlusive assembly and leaflet occursearlier in the leaflet’s travel. In contrast, a more planar or flatimplant structure in which the sheets of the implant cover a greaterproportion of the tricuspid valve structure may be more advantageouswhen commissural regurgitation is present despite substantially normalleaflet function. These and other considerations are described below infurther detail.

In one aspect, implants according to the present disclosure may vary incurvature when in the expanded state. Examples of varying curvature areprovided in FIGS. 29A-29C. More specifically, FIG. 29A is an elevationview of an implant 2900A that has a proximally concave shape whendeployed/expanded, FIG. 29B is an elevation view of an implant 2900Bthat has a distally concave shape when deployed/expanded, FIG. 29C is anelevation view of an implant 2900C including a proximally concaveproximal portion and a distally concave distal portion. For clarity andsimplicity, each of implant 2900A-2900C are shown in a simplified viewin which overall shape is emphasized and certain elements of eachimplant are omitted. Accordingly, and unless stated otherwise, implants2900A-2900C may generally include elements of and be in accordance withany other implementation discussed herein. For example, FIGS. 29A-29Cgenerally omit details regarding the frames of the correspondingimplants; however, it should be understood that such frames may be inaccordance with any frame style disclosed herein.

Referring first to FIG. 29A, implant 2900A includes a distal end 2902Aand a proximal end 2904A such that a longitudinal axis 2906A of implant2900A extends between distal end 2902A and proximal end 2904A. Implant2900A includes a frame 2908A that supports an occlusive assembly 2910Aat distal end 2902A. As shown, occlusive assembly 2910A includes aninner sheet 2912A; however, in other implementations, occlusive assembly2910A may include an occlusive body instead of or in addition to innersheet 2912A. For example, occlusive assembly 2910A may include a bulb-or bullnose-shaped occluder about which inner sheet 2912A extends.Implant 2900A further includes an outer sheet 2914A supported on frame2908A at proximal end 2904A such that an annular opening 2916A isdefined between inner sheet 2912A and outer sheet 2914A.

FIG. 29A shows implant 2900 in the expanded state (e.g., followingdeployment). As shown, implant 2900A has a proximally concave shapedefined by a radius of curvature (RC-A) such that implant 2900A has anoverall bowl-like shape. Implant 2700 of FIGS. 27 and 28 is an exampleof a proximally concave implant according to this disclosure and isdiscussed above in further detail. Notably, while illustrated as beinghemispherical, implant 2900A may alternatively have an ovoid or similarrounded but non-spherical shape.

RC-A may differ in implementations of this disclosure depending on thespecific application and needs of the patient. For example, when theoverall diameter of proximal end 2904A is held constant, RC-A generallycontrols the position of distal end 2902A and occlusive assembly 2910Arelative to proximal end 2904A. More specifically, as RC-A increases,implant 2900A takes on a shallower geometry when in the expanded shapesuch that distal end 2902A is closer to the valve annulus followingdeployment. Conversely, as RC-A decreases, implant 2900A takes on adeeper shape such that distal end 2902A and occlusive assembly 2910Adeploy further within the ventricle. As noted above, placement ofocclusive assembly 2910A relative to the valve annulus determines howand when the valve leaflets contact and seal against occlusive assembly2910A and, as a result, RC-A may be chosen to account for various needsand idiosyncrasies of a particular patient.

For example, the proximally concave/distally convex shape illustrated inFIG. 29A generally includes larger and more accessible gaps as comparedto the distally concave/proximally convex design illustrated in FIG. 29Band discussed below in further detail. As a result, proximally concaveimplants according to the present disclosure may allow for easier andmore accurate placement of other cardiac devices, such as pacemakerleads, though the implant. Proximally concave implants according to thisdisclosure may also be readily inverted. Such invertibility canfacilitate removal of the implant at a later date as the implant can befunneled and pulled back into a retrieval catheter.

Regardless of concavity, implants according to this disclosure havingframes formed of metal or other radiopaque materials may furtherfacilitate placement of a pacemaker lead by being visible on fluoroscopyand providing a target for delivering the pacemaker lead. The frame ofthe implant may also provide constraints for the pacemaker lead toreduce movement of the lead following delivery and implantation. Amongother things, such reinforcement of the lead may prevent or reduce thelikelihood that the pacemaker lead may obstruct or otherwise interferewith movement of the valve leaflets.

Referring next to FIG. 29B, implant 2900B includes a distal end 2902Band a proximal end 2904B such that a longitudinal axis 2906B of implant2900B extends between distal end 2902B and proximal end 2904B. FIG. 29Bshows implant 2900B in the expanded state about longitudinal axis 2906B.Implant 2900B includes a frame 2908B that supports an occlusive assembly2910B at distal end 2902B and that is shown including an inner sheet2912B as well as an occlusive body 2913B. In other implementations,occlusive assembly 2910B may instead include only one of inner sheet2912B and occlusive body 2913B. Implant 2900B further includes an outersheet 2914B supported on frame 2908B at proximal end 2904B such that anannular opening 2916B is defined between inner sheet 2912B and outersheet 2914B. When in the expanded state (e.g., following deployment)implant 2900B has a distally concave shape defined by a radius ofcurvature (RC-B) such that implant 2900B has an overall funnel-likeshape. Examples of implants with a similar shape include implant 20 andimplant 2500, discussed above in further detail.

Like RC-A of implant 2900A, RC-B of implant 2900B may differ inimplementations of this disclosure depending on the specific applicationand needs of the patient. Among other things, the distally concavedesign of implant 2900B ensures that initial contact between the valveleaflets and implant 2900B is with occlusive assembly 2910B as opposedto a portion of frame 2908B, as may occur in the distally concave designof implant 2900A. More generally, the distally concave shape reduces theoverall size of the implant portion within the ventricle, reducing thelikelihood that the implant may obstruct or otherwise interfere withcardiac structures and their respective functions. For example, thedistally concave shape reduces contact between the valve leaflets andthe implant, thereby reducing the likelihood that the implant willinterfere with or otherwise impede travel of the leaflets. As anotherexample, the distally convex shape may reduce the likelihood that theimplant will interfere with or obstruct the coronary sinus or similarvessels of the heart.

Implant 2900C includes a distal end 2902C and a proximal end 2904C suchthat a longitudinal axis 2906C of implant 2900B extends between distalend 2902C and proximal end 2904C. FIG. 29C shows implant 2900C in theexpanded state about longitudinal axis 2906C. Implant 2900C includes aframe 2908C that supports an occlusive assembly 2910C at distal end2902C and that is shown including an inner sheet 2912C. In otherimplementations, occlusive assembly 2910C may further or alternativelyinclude an occlusive body. Implant 2900C also includes an outer sheet2914C supported on frame 2908C at proximal end 2904C such that anannular opening 2916C is defined between inner sheet 2912C and outersheet 2914C.

Implant 2900C includes both proximally and distally concave portions.More specifically, 2900C includes proximal portion 2920C that has aproximally concave shape. Implant 2900C transitions into a distalportion 2922C that has a distally concave shape. In the implementationillustrated in FIG. 29C, distal portion 2922C further transitions into aproximally concave cap portion 2924C that includes occlusive assembly2910C and, more specifically, inner sheet 2912C. In otherimplementations, distal portion 2922C may instead terminate in anocclusive body, such as central occluder 50 of implant 20 or centralocclusive body 2550 of implant 2500.

When in the expanded state (e.g., following deployment) the shape ofimplant 2900C may be defined by at least two radii of curvature. Morespecifically, the shape of implant 2900C may be defined by a radius ofcurvature (RC-C) corresponding to proximal portion 2920C (i.e., theproximally concave portion of implant 2900C) and a radius of curvature(RC-D) corresponding to the distal portion 2922C (i.e., the distallyconcave portion of implant 2900C). To the extent an implementation ofthis disclosure further includes proximally concave cap portion 2924C,implant 2900C may be further defined by a radius of curvature (RC-E)corresponding to proximally concave cap portion 2924C. In certainimplementations, RC-E and RC-C may be the same; however RC-E and RC-Cmay also differ such that proximally concave cap portion 2924C may havea more or less pronounced curvature than proximal portion 2920C.

While each of implant 2900A, implant 2900B, and implant 2900C have anoverall curved shape, implants according to this disclosure may alsohave non-curved shapes when deployed. Examples of such non-curvedimplants are provided in FIGS. 30A and 30B. More specifically, FIG. 30Ais an elevation view of an implant 3000A having a conical shape whendeployed while FIG. 30B is an elevation view of an implant 3000B havinga flat or planar shape when deployed. Like FIGS. 29A and 29B, forclarity and simplicity, each of implant 3000A and implant 3000B areshown in a simplified view in which overall shape is emphasized andcertain elements of each implant are omitted. Accordingly, and unlessstated otherwise, implant 3000A and implant 3000B may generally includeelements of and be in accordance with any other implementation discussedherein.

Referring to FIG. 30A, implant 3000A includes a distal end 3002A and aproximal end 3004A such that a longitudinal axis 3006A of implant 3000Aextends between distal end 3002A and proximal end 3004A. Implant 3000Aincludes a frame 3008A that supports an occlusive assembly 3010A atdistal end 3002A. As shown, occlusive assembly 3010A includes an innersheet 3012A and an occlusive body 3013A. In other implementations,occlusive assembly 3010A may instead include only one of inner sheet3012A and occlusive body 3013A. Implant 3000A further includes an outersheet 3014A supported on a proximal portion of frame 3008A such that anannular opening 3016A is defined between inner sheet 3012A and outersheet 3014A.

FIG. 30A shows implant 3000 in the expanded state (e.g., followingdeployment). As shown and in contrast to the curved funnel shape ofimplant 2900B, implant 3000A has a straight-sided funnel shape. Stateddifferently, when deployed, implant 3000A has a distally expandingconical or frustoconical shape.

Like implant 2900A and implant 2900B, implant 3000A may be modified tovary the degree to which occlusive assembly 3010A enters the ventriclewhen implant 3000A is deployed within the heart. For example, thegeneral shape of implant 3000B may be determined by an angle θ, whichmay be defined as the angle between the sides of frame 3008A andlongitudinal axis 3006A of implant 3000A when implant 3000A is in theexpanded/deployed state. Assuming other dimensions of implant 3000A(e.g., maximum diameter at proximal end 3004A) remain substantiallyconstant, varying θ changes overall length of implant 3000A whenexpanded and, as a result, the depth of occlusive assembly 3010A withinthe ventricle. More specifically, reducing θ increases the overalllength of implant 3000A and the depth of occlusive assembly 3010A withinthe ventricle when implant 3000A is deployed. Conversely, increasing θreduces the overall length of implant 3000A when deployed (e.g., resultsin implant 3000A being more planar in the expanded state) and the depthof occlusive assembly 3010A within the ventricle.

Referring next to FIG. 30B, implant 3000B expands into a flat or planarshape when deployed. Implant 3000B includes a radially inward portion3002B and a radially outward portion 3004B relative to a longitudinalaxis 3006B. When in the collapsed state (e.g., when implant 3000B iscollapsed about longitudinal axis 3006B during delivery), radiallyinward portion 3002B forms a distal or leading end of implant 3000Bwhile radially outward portion 3004B forms a proximal end of implant3000B. Like other implants disclosed herein, implant 3000B includes aframe 3008B that supports an occlusive assembly 3010B at radially inwardportion 3002B. As shown, occlusive assembly 3010B includes an innersheet 3012B. In other implementations, occlusive assembly 3010B mayfurther or alternatively include an occlusive body 3013B, which FIG. 30Bshows in dashed lines. Implant 3000B further includes an outer sheet3014B supported on a proximal portion of frame 3008B such that anannular opening 3016B is defined between inner sheet 3012A and outersheet 3014B.

Planar implants, such as implant 3000B, may be particularly advantageousin cases where regurgitation results despite substantially normal valveleaflet travel. When deployed, implant 3000B may be positioned along thefloor of the atrium across the valve annulus with occlusive assembly3010B centrally located or approximately centrally located. Inimplementations in which occlusive assembly 3010B includes occlusivebody 3013B, occlusive body 3013B may project into the valve annulus oracross the valve annulus into the ventricle, depending on its size andshape. When the valve is in the closed position and with implant 3000Bproperly positioned, the valve leaflets contact and seal againstocclusive assembly 3010B. In this position, portions of occlusiveassembly 3010B, such as inner sheet 3012B, may extend over the leafletsand, in particular, the commissures between the leaflets. By doing so,inner sheet 3012B provides an additional and expanded sealing surfacefor the leaflets and may cover at least a portion of commissural gapsthat may be present, thereby reducing regurgitation. In addition toinner sheet 3012B, additional regurgitation reduction may be provided byouter sheet 3014B, which may similarly seal against the leaflets andcover commissural gaps that may be present toward the outward edge ofthe valve annulus.

IX. Alternative Frame Configurations

As previously discussed, implants according to the present disclosureinclude a frame configured to support a distal occlusive assembly. Theframe may further support or otherwise be coupled to one or more thinsheets or similar structures. In certain implementations such sheets mayinclude a proximal or outer sheet configured to contact the atrial floorand/or a distal or inner sheet included in the occlusive assembly (e.g.,as a “skirt” extending circumferentially around an occlusive body of theocclusive assembly).

In addition to providing structural integrity, frames of implantsaccording to this disclosure are configured to be expandable about alongitudinal axis of the implant. More specifically, frames of implantsaccording to the present disclosure are configured to transition betweena collapsed state and an expanded state. The collapsed state maycorrespond, for example, to a state of the implant during delivery usinga delivery tool, such as tool 15 (shown in FIG. 1A), tool 1115 (shown inFIGS. 11A-11B), or delivery tool 300 (shown in FIG. 13 ), each of whichis discussed above in detail. In contrast, the expanded state maycorrespond to a state of the implant following delivery and deploymentwithin a patient heart. Implant frames according to this disclosure maybe biased into the expanded state such that the implant transitions intothe expanded state absent resistance provided by a delivery tool. Forexample, and with reference to FIG. 16 , tension control members 320 ofthe delivery tool may be coupled to a tension control line 200 of theimplant such that by applying tension to the tension control members320, a user may resist expansion of the implant. In certainimplementations, a user may apply sufficient tension to collapse theimplant (e.g., to transition the implant from the expanded state to thecollapsed state).

This disclosure previously described various example frame styles. Forexample, FIGS. 2-8 and 12 include a first style of frame for a distallyconcave implant in which radially extending spokes support arcuate petalportions circumferentially distributed about a central occluder. FIGS.25 and 26 illustrate a similar frame style albeit with the furtherinclusion of inner arcuate petal portions configured to support an innersheet. FIGS. 27 and 28 introduce the concept of a proximally concaveframe formed by joining an inner/distal set of circumferentiallydistributed arcuate petals to an outer/proximal set of circumferentiallydistributed arcuate petals. FIGS. 29A-30B expand on these general framestyles by providing additional examples of overall frame shapes andconfigurations.

To further illustrate the scope of frames contemplated by thisdisclosure, FIGS. 31-33 provide additional examples of frame styles thatmay be used in implants according to the present disclosure. Notably,while each of FIGS. 31-33 describe the alternative frame styles asapplied to a proximally concave implant (similar to implant 2700 ofFIGS. 27 and 28 ), the concepts and structures illustrated in FIGS.31-33 may be applied to implants having distally concave, frustoconical,planar, or other overall shapes. Notably, FIGS. 31-33 omit certainfeatures of the illustrated implants for purposes of clarity. Forexample, each of FIGS. 31-33 omit a backside of the depicted implants(relative to the illustrated perspective) to more clearly illustrate thestructure and configuration of the frames of the implants.

FIG. 31 illustrates an implant 3100 having a first alternative frameconfiguration. Implant 3100 includes a distal end 3102 and a proximalend 3104 such that a longitudinal axis 3106 of implant 3100 extendsbetween distal end 3102 and proximal end 3104. Implant 3100 includes aframe 3108 that supports an occlusive assembly 3110 at distal end 3102.As shown, occlusive assembly 3110 includes an inner sheet 3112; however,in other implementations, occlusive assembly 3110 may include anocclusive body instead of or in addition to inner sheet 3112. Implant3100 further includes an outer sheet 3114 supported on a proximalportion of frame 3108 such that an annular opening 3116 is definedbetween inner sheet 3112 and outer sheet 3114.

Similar to frame 2755 of implant 2700, frame 3108 of implant 3100includes a distal frame portion 3118 including a first set ofcircumferentially distributed arcuate petal portions, such as arcuatepetal portion 3120A and arcuate petal portion 3120B, and a proximalframe portion 3138 including a second set of circumferentiallydistributed arcuate petal portions, such as arcuate petal portion 3140Aand arcuate petal portion 3140B. As described in the context of FIGS. 27and 28 , above, arcuate petals portions according to this disclosure maybe ovate, diamond-shaped, or have any similar elongate shape (e.g.,generally diamond shaped albeit with rounded vertices or curved edges).More generally, arcuate petal portions according to this disclosure mayhave any suitable shape that enables collapsing and expanding of theframe and other functionality described herein (e.g., support of fabricsheets, such as inner sheet 3112 and outer sheet 3114).

As shown in FIG. 31 , adjacent arcuate petal portions of distal frameportion 3118 may be joined at or near their respective co-vertices. Forexample, arcuate petal portion 3120A and arcuate petal portion 3120B arejoined at a junction 3126 disposed at the corresponding co-vertices ofarcuate petal portion 3120A and arcuate petal portion 3120B. Adjacentarcuate petal portions of proximal frame portion 3138 likewise may bejoined at or near their respective co-vertices. For example, arcuatepetal portion 3140A and arcuate petal portion 3140B are joined at ajunction 3146 disposed at the corresponding co-vertices of arcuate petalportion 3140A and arcuate petal portion 3140B

Arcuate petal portions of distal frame portion 3118 may be joined torespective arcuate petal portions of proximal frame portion 3138. Forexample, arcuate petal portion 3120A is coupled to arcuate petal portion3140A by a longitudinal member 3148 extending between a proximal vertex3125 of arcuate petal portion 3120A and a distal vertex 3145 of arcuatepetal portion 3140A.

As illustrated in FIG. 31 , longitudinal member 3148 extending betweenarcuate petal portion 3120A and arcuate petal portion 3140A issubstantially longer than longitudinal member 2790 extending betweenarcuate petal portion 2780A and arcuate petal portion 2785A of implant2700 (shown in FIG. 28 ).

Although FIG. 31 illustrates longitudinal members (e.g., longitudinalmember 3148) as extending between the proximal vertices of the first setof arcuate petal portions and the distal vertices of the second set ofarcuate petal portions, in other implementations, longitudinal membersmay extend between other locations of frame 3108. For example, incertain implementations, longitudinal members may be offset from thearcuate petal portions such that the longitudinal members extend betweenthe circumferential junctions of the arcuate petal portions. So, forexample and with reference to FIG. 31 , longitudinal members may extendbetween the junctions of the first set of arcuate petal portions (e.g.,junction 3126) and the junctions of the second set of arcuate petalportions (e.g., junction 3146). In other implementations, the first setof arcuate petal portions can be rotationally offset from the second setof arcuate petal portions such that the junctions of one set align withthe vertices of the other set. In such implementations, longitudinalmembers may extend between the junctions of one set and the vertices ofthe other. So, for example, longitudinal members may extend betweenjunctions of the first set of arcuate petal portions (e.g., junction3126) and the distal vertices of the second set of arcuate petalportions (e.g., distal vertex 3145). Alternatively, longitudinal membersmay extend between the proximal vertices of the first set of arcuatepetal portions (e.g., proximal vertex 3125) and the junctions of thesecond set of arcuate petal portions (e.g., junction 3146).

In implementations of the present disclosure, either of the inner sheetor the outer sheet may define one or more internal pockets. For example,in certain implementations, the sheet may include two or more layersstitched or otherwise coupled together to form internal pockets betweenadjacent layers. In one implementation, the adjacent layers may includea first layer disposed on a proximal or inner surface of the implantframe and a second layer disposed on a distal or outer surface of theimplant frame such that the frame also extends between the layers. Inother implementations, the layers forming the internal pockets may bedisposed entirely on the proximal/inner surface of the frame or thedistal/outer surface of the frame. Pockets formed in this way may befilled, such as with additional layers of fabric, batting, or awater-absorbing material, such as a hydrogel. In such cases, the fillinggenerally forms a pad that may increase the distance between theoccluding surface/sheet and the underlying frame of the implant, therebypreventing and padding contact between valve leaflets and the frame.

FIG. 32 illustrates an implant 3200 with another alternative frameconfiguration. Implant 3200 includes a distal end 3202 and a proximalend 3204 such that a longitudinal axis 3206 of implant 3200 extendsbetween distal end 3202 and proximal end 3204. Implant 3200 includes aframe 3208 that supports an occlusive assembly 3210 at distal end 3202.As shown, occlusive assembly 3210 includes an inner sheet 3212; however,in other implementations, occlusive assembly 3210 may include anocclusive body instead of or in addition to inner sheet 3212. Implant3200 further includes an outer sheet 3214 supported on a proximalportion of frame 3208 such that an annular opening 3216 is definedbetween inner sheet 3212 and outer sheet 3214.

Frame 3208 of implant 3200 includes a distal frame portion 3218including a first set of circumferentially distributed arcuate petalportions, such as arcuate petal portion 3220A and arcuate petal portion3220B, and a proximal frame portion 3238 including a second set ofcircumferentially distributed arcuate petal portions, such as arcuatepetal portion 3240A and arcuate petal portion 3240B.

The first or inner set of arcuate petal portions of implant 3200 areshown as being substantially similar to those of implant 3100. Thesecond set arcuate petal portions of implant 3200, on the other hand,have a distally open shape in contrast to the ovate shape of implant3100. More specifically, each arcuate petal portion of the second set ofarcuate petal portions is formed by a pair of longitudinal members andan arcuate frame portion. For example, arcuate petal portion 3240A isformed by a longitudinal member 3248A, a longitudinal member 3248B, andan arcuate frame portion 3249, which extends between longitudinal member3248A and longitudinal member 3248B. As illustrated, each longitudinalmember extends from a respective junction of the first set of arcuatepetal portions. For example, longitudinal member 3248A extends from ajunction 3226 between arcuate petal portion 3220A and arcuate petalportion 3220B. Like noted above with respect to implant 3100, the firstand second set of arcuate petal portions of implant 3200 may berotationally offset from the configuration illustrated in FIG. 32 suchthat the longitudinal members instead extend from proximal vertices(e.g., proximal vertex 3125) of the first set of arcuate petal portions.

FIG. 33 illustrates an implant 3300 having yet another alternative frameconfiguration. Implant 3300 includes a distal end 3302 and a proximalend 3304 such that a longitudinal axis 3306 of implant 3300 extendsbetween distal end 3302 and proximal end 3304. Implant 3300 includes aframe 3308 that supports an occlusive assembly 3310 at distal end 3302.As shown, occlusive assembly 3310 includes an inner sheet 3312; however,in other implementations, occlusive assembly 3310 may include anocclusive body instead of or in addition to inner sheet 3312. Implant3300 further includes an outer sheet 3314 supported on a proximalportion of frame 3308 such that an annular opening 3316 is definedbetween inner sheet 3312 and outer sheet 3314.

Frame 3308 of implant 3300 includes a distal frame portion 3318including a set of circumferentially distributed arcuate petal portions,such as arcuate petal portion 3320A and arcuate petal portion 3320B.Frame 3308 further includes a proximal frame portion 3338 including asecond set of circumferentially distributed arcuate petal portions, suchas arcuate petal portion 3340A and arcuate petal portion 3340B.

As shown in FIG. 33 , the first or inner set of arcuate petal portionsof implant 3300 are shown as being substantially like those of implant3100. However, in contrast to implant 3100, each arcuate petal portionof the second set of arcuate petal portions of implant 3300 is formed byarcuate frame members extending between longitudinal members. Forexample, arcuate petal portion 3340A is formed by arcuate frame member3341A and arcuate frame member 3341B, which extend between longitudinalmember 3348A and longitudinal member 3348B.

As shown in FIG. 33 , longitudinal member 3348A and longitudinal member3348B extend from respective junctions of the first set of arcuate petalportions. For example, longitudinal member 3348A extends from a junctionformed between arcuate petal portion 3320A and arcuate petal portion3320B. Like noted above with respect to implant 3100, the first andsecond set of arcuate petal portions of implant 3300 may be rotationallyoffset from the configuration illustrated in FIG. 33 such that thelongitudinal members instead extend from proximal vertices (e.g.,proximal vertex 3325) of the first set of arcuate petal portions.

In the implementation shown, arcuate frame member 3341A is proximal andarcuate frame member 3341B and each of arcuate frame member 3341A andarcuate frame member 3341B are distally concave. In otherimplementations, one or both of arcuate frame member 3341A and arcuateframe member 3341B may be proximally concave. Also, in otherimplementations, the combination of arcuate frame member 3341A andarcuate frame member 3341B may be replaced with a single arcuate framemember or supplemented with any suitable number of additional arcuateframe members. Moreover, the number of arcuate frame members may varybetween arcuate petal portions. So, for example, certain arcuate petalportions may include no or only a single arcuate frame member whileothers may include two or more.

As previously discussed herein, implants according to this disclosureare capable of transitioning between an expanded state (e.g., whenimplanted) and a collapsed state (e.g., during delivery). The transitionfrom collapsed state into the expanded state causes a proximal portionof the frame of the implant to travel radially outward away from thecentral longitudinal axis of the implant. The transition into theexpanded state may also include a longitudinal shift of the proximalportion of the frame. As a result, as the implant expands, it extendsradially outward but reduces in length along the longitudinal axis.

The presence, size, and quantity of arcuate petal portions contributesto the overall length of the implant when in the collapsed state. Whenan arcuate petal portion is collapsed (e.g., when the implant is in thecollapsed state), the arcuate petal portion undergoes each ofcircumferential compression and longitudinal elongation. As a result, afirst implant with more and/or larger arcuate petal portions than asecond implant will typically have a longer collapsed length than thesecond implant even when the first and second implants have the sameoverall dimensions when in their respective expanded states.

The relationship between collapsed length and arcuate petal portioncharacteristics may be leveraged to design implants for specificapplications. For example, if a surgeon anticipates that delivery andimplantation may be challenging, a first implant having a frame withmore and/or longer longitudinal members may be selected over a secondimplant having a frame with more and/or larger arcuate petal portionsdue to the first implant having a shorter and more maneuverable lengthwhen in the collapsed state (i.e., during delivery). In contrast, ifadditional devices (e.g., pacemaker leads) are to be subsequentlyimplanted in the patient, the surgeon may opt for the second implant dueto the size, shape, and positioning of the openings defined by thearcuate petal portions providing additional options and flexibility fordelivery and support of the additional devices.

As another example, designs with a higher proportion of longitudinalmembers tend to exert less radial force when transitioning between fromthe collapsed state to the expanded state and may generally exhibitlower radial rigidity. Accordingly, an implant frame with a higherproportion of longitudinal members and a lower proportion of arcuatepetal portions (or similar expanding structures) may be selected inimplementations in which cardiac tissue may be damaged by higher radialforces or that may require the implant to conform to more complexgeometry within the heart.

FIGS. 31-33 illustrate alternative frame configurations according tothis disclosure and are limited to proximally concave designs. The frameconfiguration may nevertheless be readily adapted to other implantshapes including, but not limited to, implants having overall shapesthat are distally concave, frustoconical, planar, or includecombinations of different concavities. FIG. 34-35B, for example,illustrate certain frame alternatives implemented in implants having acombination of a proximally concave distally concave distal portions.

FIG. 34 illustrates an implant 3400 having a frame configuration similarto that of implant 3300 of FIG. 33 . Implant 3400 includes a distal end3402 and a proximal end 3404 such that a longitudinal axis 3406 ofimplant 3400 extends between distal end 3402 and proximal end 3404.Implant 3400 includes a frame 3408 that may support an occlusiveassembly at distal end 3302. FIG. 34 omits the occlusive assembly toshow the various features and configuration of frame 3408 more clearly.Like other implementations discussed herein, when included, theocclusive assembly may include an occlusive body and/ or an inner sheet.Implant 3400 may also include an outer sheet (not shown in FIG. 34 )supported on a proximal portion of frame 3408 such that an annularopening is defined between the inner sheet/occlusive assembly and theouter sheet.

Frame 3408 of implant 3400 includes a distal frame portion 3418including a set of circumferentially distributed arcuate petal portions,such as arcuate petal portion 3420A and arcuate petal portion 3420B.Frame 3408 further includes a proximal frame portion 3438 including asecond set of circumferentially distributed arcuate petal portions, suchas arcuate petal portion 3440A and arcuate petal portion 3440B. Eacharcuate petal portion of the second set of arcuate petal portions ofimplant 3400 is formed by arcuate frame members extending betweenlongitudinal members. For example, arcuate petal portion 3440A is formedby arcuate frame member 3441A and arcuate frame member 3441B, whichextend between longitudinal member 3448A and longitudinal member 3448B.Longitudinal member 3348A and longitudinal member 3348B extend fromrespective proximal tips of arcuate petal portions of the first set ofarcuate petal portions, e.g., longitudinal member 3448A extends from aproximal tip 3426 of arcuate petal portion 3420A.

In contrast to implant 3300 of FIG. 33 , which has a proximally concaveshape, implant 3400 of FIG. 34 has varying concavity, like implant 2900Cof FIG. 29C. More specifically, implant 3400 includes each of a proximalportion 3450 that is proximally concave, a distal portion 3452 that isdistally concave, and a cap portion 3454 that is proximally concave.

Implant 3400 further includes circumferentially distributed anchormembers, such as anchor member 3456 and anchor member 3458. Anchormember 3456 is part of a first set of anchor members that extendradially outward from a proximal tip of a respective arcuate framemember. Specifically, each anchor member of the first set of anchormembers extends from a proximal tip of the distal frame member of eacharcuate petal portion. So, for example, anchor member 3456 extends fromthe proximal tip of arcuate frame member 3441B. Anchor member 3458, onthe other hand, is part of a second set of anchor members that extendradially outward from junctions between arcuate tip members andlongitudinal members. Specifically, each anchor member of the second setof anchor members extends from a respective junction between theproximal frame member of each arcuate petal portion and eachlongitudinal member. So, for example, anchor member 3458 extends fromthe junction between arcuate frame member 3441A and longitudinal member3348A. In other implementations, anchor members may alternatively oradditional be disposed at other locations of the frame including, butnot limited, to the proximal tip of the proximal arcuate frame member(e.g., arcuate frame member 3441A) and the junctions formed between thedistal arcuate frame members and the longitudinal members.

FIGS. 35A and 35B illustrate another implant 3500 having an overallshape with varying concavities. Implant 3500 includes a distal end 3502and a proximal end 3504 such that a longitudinal axis 3506 of implant3500 extends between distal end 3502 and proximal end 3504. Implant 3500includes a frame 3508 that may support an occlusive assembly 3510 atdistal end 3302. FIG. 35A omits the occlusive assembly to show thevarious features and configuration of frame 3508 more clearly while;however, FIG. 35B includes occlusive assembly 3510. Like otherimplementations discussed herein, occlusive assembly 3510 includes aninner sheet 3512 but may alternatively or additionally include anocclusive body. Implant 3500 may also include an outer sheet 3514 (alsoshown in FIG. 35B), which is supported on a proximal portion of frame3508 such that an annular opening 3516 is defined between inner sheet3512 and outer sheet 3514.

Frame 3508 of implant 3500 includes a distal frame portion 3518including a set of circumferentially distributed arcuate petal portions,such as arcuate petal portion 3520A and arcuate petal portion 3520B(each labelled in FIG. 35A). Frame 3508 further includes an intermediateframe portion 3538 including a second set of circumferentiallydistributed arcuate petal portions, such as arcuate petal portion 3540Aand arcuate petal portion 3540B (each labelled in FIG. 35A) and aproximal frame portion 3558 including a third set of circumferentiallydistributed arcuate petal portions, such as arcuate petal portion 3560Aand arcuate petal portion 3560B (each labelled in FIG. 35A). As mostclearly seen in FIG. 35A, the first and second set of arcuate petalportions are aligned to facilitate joining of each arcuate petal portionof the first set of arcuate petal portions to a respective arcuate petalportion of the second set of petal portions. For example, a proximal tipof arcuate petal portion 3520A is joined to a distal tip of arcuatepetal portion 3540A. In contrast, the second and third sets of arcuatepetal portions are rotationally offset and longitudinally overlap eachother. For example, arcuate petal portion 3540A is rotationally offsetfrom and longitudinally overlaps arcuate petal portion 3560A. Adjacentarcuate petal portions of the second set and the third set may alsoshare common frame elements. For example, arcuate petal portion 3540Aand arcuate petal portion 3560A each include frame element 3562.

Like implant 3400 of FIG. 34 and implant 2900C of FIG. 29C, implant 3500of FIGS. 35A and 35B has varying concavity. More specifically, implant3500 includes each of a proximal portion 3550 that is proximallyconcave, a distal portion 3552 that is distally concave, and a capportion 3554 that is proximally concave.

Also, like implant 3400, implant 3500 includes circumferentiallydistributed anchor members, such as anchor member 3556. Anchor member3556 is part of a set of anchor members that extend radially outwardfrom each junction between adjacent arcuate petal portions of the thirdset of arcuate petal portions. So, for example, anchor member 3556extends from a junction 3564 between arcuate petal portion 3560A andarcuate petal portion 3560B. In other implementations, anchor membersmay alternatively or additional be disposed at other locations of theframe including, but not limited, junctions between adjacent arcuatepetal portions of the second set of arcuate petal portions and theproximal tips of the arcuate petal portions of the third set of arcuatepetal portions.

Implementations of this disclosure corresponding to implant 3500 are notlimited to any sizes or dimensions and may be modified or customized tomeet the needs of patients and specific applications. Nevertheless, incertain implementations, a proximal radially outward edge 3563 of innersheet 3512 may be from and including about 16 mm to and including about30 mm. For example, in one specific implementation proximal radiallyoutward edge 3563 may be 24 mm. Similarly, a distal radially inward edge3565 of outer sheet 3514 may be from and including about 35 mm to andincluding about 55 mm. For example, in one specific implementation,proximal radially outward edge 3563 may be 42 mm. A proximal radiallyoutward edge 3566 of implant 3500 may be from and including about 42 mmto and including about 68 mm. In one specific example, proximal radiallyoutward edge 3566 may be 56 mm. In implementations in which implant 3500includes anchor members, such as anchor member 3556, at least a portionof the anchor members may be distributed around a common circumference3567 of implant 3500. Although the diameter of common circumference 3567may vary, in at least certain implementations, common circumference 3567may have a diameter from and including about 42 mm to and includingabout 68 mm. For example, common circumference 3567 may have a diameterof 54 mm. As a final example, the overall height of implant 3500 in theexpanded state may vary; however, in at least certain implementations,the overall height of implant 3500 may be from and including about 26 mmto and including about 48 mm and, in one specific implementation, may be36 mm.

While only a select few implementations of this disclosure are shown ordescribed as including anchor members (e.g., protruding anchor members105 of frame 55), such anchor members may be added to or otherwiseincluded in any implant design discussed herein. Similarly, while thisdisclosure discusses control of implant expansion by a tension controlline in the context of FIGS. 12-22 , such functionality may be adaptedto and included in any other implant discussed herein.

X. Alternative Delivery Tool Configuration

FIGS. 36-38 illustrate a delivery device 3600 according to analternative implementation of the present disclosure. More specifically,FIGS. 36 and 37 are schematic illustrations of a distal portion 3602 ofdelivery device 3600 in a collapsed and expanded state, respectively,and with a valve repair implant omitted for clarity. FIG. 38 is aphotograph of delivery device 3600 and, in particular, a proximal viewof distal portion 3602 including a valve repair implant 3800 coupled todelivery device 3600. Delivery device 3600 includes multiple variationson features previously discussed in this disclosure, each of which isdescribed below in further detail. Notably, while delivery device 3600incorporates multiple features that differ from previously disclosedimplementations, each feature should be considered independent and, as aresult, may be readily adapted for inclusion in other implementationsincluded in this disclosure.

As shown in FIGS. 36-38 , delivery device 3600 includes a deliverycatheter 3604 and an extension member 3606 extending from distal portion3602. In certain implementations and as discussed below in furtherdetail, extension member 3606 may be selectively extended and retractedfrom delivery catheter 3604 during deployment of valve repair implant3800.

During deployment and implantation of valve repair implant 3800, valverepair implant 3800 is releasably coupled to a control arm assembly 3608of delivery device 3600. As described below in further detail, thecontrol arm assembly can be manipulated to expand laterally or collapsemedially relative to a longitudinal axis 3603 of delivery device 3600.Due to the coupling of the control arm assembly 3608 to valve repairimplant 3800, such expansion and collapse of the control arm assembly3608 results in corresponding expansion and collapse of valve repairimplant 3800.

During delivery and deployment of valve repair implant 3800, valverepair implant 3800 may be coupled to delivery device 3600 by a cinchline 3614 (shown in FIGS. 37 and 38 ). As illustrated, cinch line 3614forms a loop that extends distally from delivery catheter 3604 androutes through loops, rings, apertures, or similar features of each ofthe control arm assembly 3608 and valve repair implant 3800 to couplevalve repair implant 3800 to the control arm assembly 3608. In additionto coupling valve repair implant 3800 to delivery device 3600, cinchline 3614 facilitates accurate control of expansion and collapse ofvalve repair implant 3800 during deployment and implantation. Inparticular, cinch line 3614 may be selectively tensioned during toencourage uniform expansion and collapse of valve repair implant 3800.

FIGS. 39-44 are detailed views of distal portion 3602 of delivery device3600 with various components of delivery device 3600 selectively removedto further illustrate the construction and functionality of deliverydevice 3600. FIGS. 39-44 are intended to introduce the various internalcomponents of delivery device 3600, many of which will be discussed infurther detail in later sections of this disclosure.

FIG. 39 shows delivery device 3600 with delivery catheter 3604 and asheath 3616 (shown in FIG. 38 ) removed. As shown, in at least certainimplementations, delivery catheter 3604 may be capped with a tip or acollar 3618 through which various components of delivery device 3600 mayextend. For example, each of extension member 3606 and control armassemblies (e.g., control arm assembly 3608) extend through collar 3618,which supports and maintains relative positioning of components ofdelivery device 3600, such as extension member 3606 and control armassembly 3608.

FIG. 39 further includes a cinch line tube 3620 and a cinch line tube3622, each of which extends through delivery catheter 3604 to guide andprotect cinch line 3614. In certain implementations, cinch line tube3620 and cinch line tube 3622 may be coiled tubes and may be coupled toor otherwise supported by control arm assembly 3608 such that as controlarm assembly 3608 expands and collapses, cinch line tube 3620 and cinchline tube 3622 extend and retract from delivery catheter 3604.Alternatively, cinch line tube 3620 and cinch line tube 3622 may befixed and extend from delivery catheter 3604. In still otherimplementations, cinch line tube 3620 and cinch line tube 3622 may beselectively extended and retracted by a corresponding control of acontrol assembly disposed on a proximal end of delivery catheter 3604.

FIG. 40 illustrates delivery device 3600 with cinch line 3614, cinchline tube 3620, cinch line tube 3622, and collar 3618 removed. As shown,delivery device 3600 may include a support member 3624, which may becoupled to or otherwise extend from collar 3618. Support member 3624 mayhave a cage-like structure that supports and allows longitudinaltranslation of extension member 3606. Support member 3624 may furtherinclude multiple apertures through which control arm pairs of controlarm assembly 3608 may extend.

FIG. 41 illustrates delivery device 3600 with support member 3624removed. As shown, delivery device 3600 may include a distal tube 3626within which a proximal portion of control arm assembly 3608 istranslatable to selectively expand and collapse control arm assembly3608. In certain implementations, distal tube 3626 may terminate or becapped with a diverter 3628, which directs proximal arms (such asproximal arm 3634) of control arm assembly 3608 in an at least partiallylateral/medial direction relative to longitudinal axis 3603 of deliverydevice 3600 to facilitate expansion and collapse of control arm assembly3608. In addition to or as an alternative to diverter 3628, proximalcontrol arms of control arm assembly 3608 may instead be outwardlycurved or otherwise biased into an outwardly curved shape to facilitateexpansion and collapse of control arm assembly 3608.

FIGS. 42 and 43 illustrate delivery device 3600 with distal tube 3626removed. In particular, FIG. 42 illustrates delivery device 3600 withcontrol arm assembly 3608 in a collapsed state while FIG. 43 illustratesdelivery device 3600 with control arm assembly 3608 in an expandedstate.

As shown, control arm assembly 3608 may include a proximal portion 3630including a proximal collar 3632 from which multiple proximal arms(e.g., proximal arm 3634) extend. Delivery device 3600 further includesa distal cap 3638 from which multiple distal arms (e.g., distal arm3640) of control arm assembly 3608 extend. As described in furtherdetail later in this disclosure, each of the distal arms forms a controlarm pair with a respective one of the proximal arms and each control armpair may be moved between an expanded and collapsed state by actuatingcontrol arm assembly 3608. In the specific implementation shown in FIGS.42 and 43 , actuation of control arm assembly 3608 includes proximallydriving or distally retracting proximal portion 3630 using a control armshaft 3642, which may be coupled to a control assembly of deliverydevice 3600, the control assembly including suitable controls forselectively translating control arm shaft 3642.

FIG. 44 illustrates delivery device 3600 with control arm assembly 3608removed. As shown, delivery device 3600 may include an extension membercontrol rod 3644 that extends through delivery catheter 3604 and couplesto extension member 3606 to facilitate extension and retraction ofextension member 3606 relative to delivery catheter 3604. In at leastsome implementations, a proximal end of extension member control rod3644 may be coupled to a control assembly at a proximal end of deliverycatheter 3604, the control assembly including a control element forselectively translating extension member control rod 3644.

With the foregoing in mind for context, the following sections of thisdisclosure will describe certain features of delivery device 3600 inadditional detail.

XI. Multi-Directional Steering

As discussed in the context of FIGS. 11A-11C, implementations of thepresent disclosure may include a steerable delivery catheter. Forexample, valve repair system 1100 illustrated in FIGS. 11A-11C includescatheter 1177, which may be inserted into a patient via sheath 1176 andsubsequently steered using steering control 1180. More specifically,catheter 1177 is illustrated and discussed as being steerable along asingle plane between two extents, generally illustrated by dashedoutlines 1192A and dashed outlines 1192B. Accordingly, theimplementation illustrated in FIGS. 11A-11C provides a single degree offreedom for steering catheter 1177.

Other implementations of this disclosure may include an alternativedelivery catheter configuration that provides multiple degrees offreedom. For example, delivery tools according to this disclosure may bedivided into multiple segments, each of which may be steerable along oneor more planes. Such increased maneuverability facilitates navigation ofthe delivery tool to an implant location and final placement of thevalve repair implant, among other benefits, ultimately resulting infaster, more efficient, and more accurate implantation procedures.

FIG. 45A is a side view of delivery device 3600 with an external sheathremoved and implant 3800 in a deployed and expanded configuration.Delivery device 3600 includes delivery catheter 3604, which, in certainimplementations, may be a steerable catheter. For example, deliverydevice 3600 includes each of a distal steerable section 4502 and aproximal steerable section 4504, each of which may steered independentlyfrom a control assembly (not shown) coupled to a proximal end ofdelivery catheter 3604.

Like the distal portion of catheter 1177 of valve repair system 1100,distal steerable section 4502 may be configured to bend along a plane4506. For example, the control assembly coupled to delivery catheter3604 may include a knob, lever, arm, or similar control element attachedto distal steerable section 4502 by a cable, wire, or similar controlline such that manipulating the control element bends distal steerablesection 4502 across a range of motion along plane 4506. Although theamount and range of bending may vary, in at least certainimplementations, distal steerable section 4502 may be configured to havea minimum bend radius along plane 4506 from and including about 10 mm toand including about 20 mm and in one specific implementation may have aminimum bending radius of about 15 mm. Also, in addition to includingcontrol elements adapted to steer distal steerable section 4502, thecontrol assembly may further include a mechanism (e.g., a knob, slide,button, etc.) for locking the angle of distal steerable section 4502.

Proximal steerable section 4504 may be configured to bend along a plane4508 that is coplanar to plane 4506 when delivery device 3600 is in aneutral/straight configuration. In at least some implementations,proximal steerable section 4504 may also be independently steerablealong a second plane, such as plane 4510. As illustrated, in at leastcertain implementations, plane 4510 may be orthogonal to plane 4508. Toachieve steering of proximal steerable section 4504, the controlassembly coupled to delivery catheter 3604 may include a respectiveknob, lever, arm, or similar control element for each degree of freedomof proximal steerable section 4504. Each such control element may inturn be attached to proximal steerable section 4504 by a cable, wire, orsimilar control line such that manipulating the control element bendsproximal steerable section 4504 along the corresponding plane. Althoughthe amount and range of bending may vary, in at least certainimplementations, proximal steerable section 4504 may be configured toindependently bend across each of plane 4508 and plane 4510 and to havea minimum bend radius along each plane from and including about 20 mm toand including about 30 mm and in one specific implementation may have aminimum bending radius of about 25 mm. The control assembly may furtherinclude respective mechanisms (e.g., knobs, slides, buttons, etc.) forlocking each of the steering controls for the proximal steerable section4504.

FIGS. 45B-45H further illustrate steering of delivery device 3600.First, FIGS. 45B and 45C illustrate steering of distal steerable section4502 of delivery device 3600. More specifically, FIG. 45B illustratesdistal steerable section 4502 in a substantial neutral position whileFIG. 45C illustrates steering of distal steerable section 4502 to afirst extent along plane 4506 (shown in FIG. 45A). As shown in FIG. 45B,in at least certain implementations, distal steerable section 4502 maybe steerable along plane 4506 by approximately 135 degrees; however,this disclosure is not limited to any specific bending angle of distalsteerable section 4502. For example, in certain implementations, distalsteerable section 4502 may be configured to bend up to 180 degrees ormore in a given direction. Moreover, while FIG. 45C illustrates steeringof distal steerable section 4502 in a first direction, inimplementations of this disclosure, distal steerable section 4502 may bebidirectionally steerable from the neutral state shown in FIG. 45B. Inat least certain implementations, distal steerable section 4502 may besteerable through approximately 360 degrees of bending along plane 4506.

In implementations in which delivery device 3600 is used for delivery ofimplants for tricuspid valve repair, for example, steering of distalsteerable section 4502 as illustrated in FIGS. 45B and 45C may beparticularly useful in achieving orthogonality between a longitudinalaxis of the implant being and/or distal steerable section 4502 and thevalve annulus. More specifically, during delivery of the implant to theright atrium, a clinician generally directs delivery device 3600 intothe right atrium via the inferior vena cava with delivery device 3600 inthe neutral state illustrated in FIG. 45B. Following entry into theright atrium, the clinician may steer distal steerable section 4502 toachieve and maintain substantial orthogonality of distal steerablesection 4502 and the implant with the tricuspid valve annulus untildelivery of the implant is complete.

While the specific bending radius of distal steerable section 4502 mayvary based on the size and configuration of delivery device 3600, in atleast certain implementations, distal steerable section 4502 may beconfigured to have a minimum bending radius of approximately 12.5 mm.Nevertheless, this disclosure contemplates that the overall size ofdelivery device 3600 and the bending radius of distal steerable section4502 may be varied based on patient anatomy and other considerations.

FIGS. 45D and 45E illustrate steering of proximal steerable section 4504of delivery device 3600. More specifically, FIG. 45D illustratesproximal steerable section 4504 in a substantial neutral position whileFIG. 45E illustrates proximal steerable section 4504 following bendingalong plane 4508 (shown in FIG. 45A). As shown in FIG. 45A, plane 4506and plane 4508 are coplanar when delivery device 3600 is in a neutralstate.

FIG. 45E illustrates how, in at least certain implementations, proximalsteerable section 4504 may be steerable along plane 4508 byapproximately 45 degrees; however, this disclosure is not limited to anyspecific bending angle of proximal steerable section 4504 along plane4508. For example, in certain implementations, proximal steerablesection 4504 may be configured to bend up to 60 degrees or more in agiven direction along plane 4508. Also, similar to distal steerablesection 4502, proximal steerable section 4504 may be bidirectionallysteerable along plane 4508. In certain implementations, the bendingradius of proximal steerable section 4504 along plane 4508 may be fromand including about 5 cm to and including about 7 cm, for exampleapproximately 6 cm; however, this disclosure is not limited to anyparticular bending radius for proximal steerable section 4504 alongplane 4508.

Referring again to procedures for delivery of implants for tricuspidvalve repair, steering of proximal steerable section 4504 along plane4508 may be particularly useful in controlling the height/insertion ofthe implant and distal steerable section 4502 relative to the valveannulus and for maximizing use of the atrial volume to properly alignthe implant with the valve annulus. For example, when delivery device3600 enters the right atrium via the inferior vena cava, distalsteerable section 4502 may be oriented such that proximal steerablesection 4504 and/or distal steerable section 4502 extend in a partiallylateral direction toward the atrial septum. In certain cases, such anorientation can limit the range of motion of distal steerable section4502 and, as a result, the ability of the clinician to align distalsteerable section 4502 with the valve annulus by steering distalsteerable section 4502 alone. To increase the range of motion of distalsteerable section 4502, proximal steerable section 4504 may be steeredas shown in FIG. 45E such that proximal steerable section 4504 ismaintained near or along the medial surface of the right atrium, therebyincreasing the volume of the right atrium available within which distalsteerable section 4502 may be steered and manipulated.

Finally, FIGS. 45F-45H illustrate steering of proximal steerable section4504 of delivery device 3600. More specifically, FIG. 45F illustratesproximal steerable section 4504 in a substantial neutral position whileFIG. 45G illustrates proximal steerable section 4504 following bendingalong plane 4510 (shown in FIG. 45A). As shown in FIG. 45A, plane 4510is orthogonal to each of plane 4506 and plane 4508 are coplanar whendelivery device 3600 is in a neutral state.

FIG. 45G illustrates proximal steerable section 4504 bent along plane4510 in a first direction from the neutral state illustrated in FIG. 45Fwhile FIG. 45H illustrates proximal steerable section 4504 bent alongplane 4510 in a second direction from the neutral state and opposite thefirst direction. In the specific implementation illustrated in FIGS.45F-45H, bending of proximal steerable section 4504 along plane 4510 isup to approximately 30 degrees in either direction; however, thisdisclosure is not limited to any specific bending angle of proximalsteerable section 4504 along plane 4508. More generally, in certainimplementations, proximal steerable section 4504 may be configured tobend up to about 60 degrees or more in one or both directions relativeto neutral along plane 4510.

When in use for delivering implants for tricuspid valve repair, steeringof proximal steerable section 4504 along plane 4510 may be particularlyuseful to control offset of the implant relative to the tricuspid valveannulus. After a clinician has successfully positioned an implant usingdelivery device 3600, the clinician may generally align the implant tobe orthogonal to the annulus of the tricuspid valve by steering each ofthe distal steerable section 4502 along plane 4506 and proximalsteerable section 4504 along plane 4508. Despite being orthogonallyoriented, the implant may nevertheless be misaligned with the valveannulus. For example, a longitudinal axis of the implant being offsetrelative to the longitudinal axis of the valve annulus. In suchinstances, steering of proximal steerable section 4504 along plane 4510may be used to reposition the implant to reduce the offset whilemaintain orthogonality of the implant relative to the valve annulus.

FIGS. 46-49 are photographs of a portion of a steering control assembly4600 for delivery device 3600 and, in particular, a portion of steeringcontrol assembly 4600 including steering controls. As previously noted,steering control assembly 4600 may be coupled to a proximal end ofdelivery catheter 3604.

FIG. 46 is an elevation view of steering control assembly 4600, whichincludes a first steering portion 4602, a second steering portion 4604,and a third steering portion 4606. The functions of each steeringportion are described below in further detail; however, in the specificimplementation illustrated in FIGS. 46-49 , the first, second, and thirdsteering portions generally correspond to a “primary” steeringmechanism, a “depth” steering mechanism, and an “offset” steeringmechanism, as labelled in the figures and as described below in furtherdetail.

FIG. 47 is a detailed view of first steering portion 4602, which is alsoreferred to in this disclosure as the primary steering mechanism. Whenused in conjunction with delivery device 3600, first steering portion4602 may control steering/bending of distal steerable section 4502 alongplane 4506. In at least certain implementations, such movementcorresponds to medial and lateral steering movement at the distal end ofdelivery catheter 3604. As illustrated in FIG. 47 , first steeringportion 4602 may include a steering lever 4608 or that can bemanipulated to steer distal steerable section 4502 and a locking knob4610 for locking the position of steering lever 4608 and, as a result,the direction of distal steerable section 4502 across plane 4506.

FIG. 48 is a detailed view of second steering portion 4604, which isalso referred to in this disclosure as the depth steering mechanism.When used in conjunction with delivery device 3600, second steeringportion 4604 may control steering/bending of proximal steerable section4504 along plane 4508, which is coplanar to plane 4506 (i.e., the planeof movement for distal steerable section 4502) when delivery catheter3604 is in a neutral configuration. In at least certain implementations,such movement corresponds to superior and inferior steering movement atthe distal end of delivery catheter 3604. As illustrated in FIG. 48 ,second steering portion 4604 may include a steering lever 4612 that canbe manipulated to steer proximal steerable section 4504 and a lockingknob 4614 for locking the position of steering lever 4612 and, as aresult, the direction of proximal steerable section 4504 across plane4508.

FIG. 49 is a detailed view of third steering portion 4606, which is alsoreferred to in this disclosure as the offset steering mechanism. Whenused in conjunction with delivery device 3600, third steering portion4606 may control steering/bending of proximal steerable section 4504along plane 4510, which is orthogonal to plane 4508. In at least certainimplementations, such movement corresponds to posterior and anteriorsteering movement at the distal end of delivery catheter 3604. Asillustrated in FIG. 49 , first steering portion 4602 may include asteering lever 4616 that can be manipulated to steer proximal steerablesection 4504 and a locking knob 4618 for locking the position ofsteering lever 4616 and, as a result, the direction of proximalsteerable section 4504 across plane 4510.

Steering control assembly 4600 is merely as an example implementation ofa control assembly that may be used in conjunction with delivery device3600 and other delivery devices according to this disclosure. Amongother things, the number of steerable sections, the directions anddegrees of freedom for each steerable section, the range and directionof each steerable section, and other aspects of steering controlassembly 4600 and its functionality may vary. The construction andarrangement of steering control assembly 4600 as illustrated in FIGS.46-49 are also nonlimiting and other arrangement of control assemblycomponents are fully considered within the scope of this disclosure.

XII. Extendable Sheath

During delivery of valve repair implant 3800, implant 3800 is coupled toa distal end of delivery device 3600 and, more specifically to a distalend of delivery catheter 3604 of delivery device 3600. To maintainimplant 3800 in a collapsed state and to facilitate navigation ofdelivery device 3600 and implant 3800 to an implantation location,delivery device 3600 may include a sheath that extends along an exteriorsurface of delivery catheter 3604. FIG. 50 , for example, is aphotograph of delivery device 3600 including a sheath 3616 disposed overdelivery catheter 3604 and implant 3800.

In at least certain implementations, sheath 3616 is translatablerelative to delivery catheter 3604. For example, sheath 3616 may betranslatable from an extended configuration to a retractedconfiguration. In the extended configuration, sheath 3616 may extendsufficiently beyond a distal end of delivery catheter 3604 to cover andat least partially contain implant 3800. Following delivery of implant3800 to an implantation region (e.g., into the atrium), sheath 3616 maybe retracted, thereby permitting deployment of implant 3800. In at leastcertain implementations, sheath 3616 may also be configured to bedistally re-extended following deployment and release of implant 3800.Among other things, such re-extension of sheath 3616 enables sheathingof the distal portion of delivery device 3600 for retraction and removalfrom the patient.

In at least certain implementations, sheath 3616 may include one or moreembedded radiopaque markers. For example, FIG. 51 is a radiographicimage of a delivery tool 5100 according to this disclosure. As shown,delivery tool 5100 includes a sheath 5102, which further includes aradiopaque marker in the form of a band 5104 (although other radiopaquemarkers, such as beads, strips, coils, and the like are alsocontemplated) that is embedded within a distal portion 5106 of sheath5102.

FIGS. 52 and 53 are photographs of a portion of a sheath controlassembly 5200 illustrating an example implementation of sheath controlsthat may be used in conjunction with delivery device 3600. Sheathcontrol assembly 5200 includes a knob 5202 which can be rotated toextend and retract sheath 3616; however, knob 5202 may be substitutedwith a lever, slide, or similar control element in otherimplementations. As shown in FIG. 53 , sheath control assembly 5200 mayfurther include a flush port 5204 in communication with an internalvolume of sheath 3616 to facilitate flushing of sheath 3616. Sheathcontrol assembly 5200 may further include a window 5206 and indicators5208 or similar markings to communicate the position of sheath 3616. Forexample, a proximal end of sheath 3616 may be visible through window5206 and indicators 5208 may be in the form of lines, grooves, marks,etc. disposed adjacent window 5206 with which the proximal end of sheath3616 may align to indicate the position of sheath 3616.

In at least certain implementations, sheath 3616 and sheath controlassembly 5200 may be configured to permit from and including about 5 cmto and including about 12 cm of travel. For example, in at least oneimplementation, sheath 3616 may be retractable up to 8 cm from a fullyextended configuration. As shown, sheath control assembly 5200 does notinclude a locking mechanism for locking the position of sheath 3616;however, in other implementations, sheath control assembly 5200 mayinclude a locking mechanism (e.g., a knob, clamp, pin, etc.) for lockingthe position of sheath 3616, e.g., by positively engaging a portion ofsheath 3616 within sheath control assembly 5200 or by preventingmanipulation of the control element of sheath control assembly 5200 forextending and retracting sheath 3616.

XIII. Implant Extension and Retraction

During delivery of implant 3800, implant 3800 is maintained in acollapsed configuration and may also be at least partially covered bysheath 3616. Implant 3800 may also be partially or entirely disposedwithin delivery catheter 3604 during delivery. Accordingly, followingdelivery into the patient heart and prior to final placement, implant3800 may need to be deployed from delivery catheter 3604. In addition toretracting sheath 3616, deployment of implant 3800 may include distallyextending implant 3800 from delivery catheter 3604. Once clear ofdelivery catheter 3604 and sheath 3616, implant 3800 may be selectivelyexpanded, collapsed, and located for implantation.

Due to the shape and construction of implant 3800, the total length ofimplant 3800 when collapsed may be substantially longer than the totallength of implant 3800 when expanded. To facilitate improved locationand implantation of implant 3800, delivery devices according to thisdisclosure may include a mechanism for extending implant 3800 fromdelivery catheter 3604 to a first extent for deployment. Followingdeployment, the mechanism may enable at least partialde-extension/retraction of implant 3800 to reduce the overall combinedlength of distal portion 3602 of delivery device 3600 and implant 3800.Given the confined space of the atria, such reduction in the combinedlength of delivery device 3600 and implant 3800 can providesubstantially increased maneuverability and control of delivery device3600 and implant 3800, leading to faster and more accurate implantplacement.

In certain implementations, extension and de-extension/retraction ofimplant 3800 relative to delivery catheter 3604 may be achieved byextending and retracting extension member 3606 relative to deliverycatheter 3604. As discussed in the context of FIGS. 36-38 , extensionmember 3606 extends distally from delivery catheter 3604 and supportsthe distal control arms of the control arm assemblies. During delivery,implant 3800 is attached to delivery device 3600 by coupling implant3800 to the control arm assemblies. Accordingly, given that the controlarm assemblies are coupled to extension member 3606, extension andretraction of extension member 3606 relative to delivery catheter 3604also results in extension and retraction of implant 3800 relative todelivery catheter 3604 when implant 3800 is attached to delivery device3600.

FIGS. 54A and 54B are photographs of delivery device 3600 with implant3800 attached. Specifically, FIG. 54A illustrates delivery device 3600and implant 3800 in a fully extended configuration. As previously noted,the fully extended configuration may be used to facilitate initialdeployment of implant 3800, e.g., by fully clearing implant 3800 fromsheath 3616 (not shown) and delivery catheter 3604. To achieve the fullyextended configuration, following navigation of distal portion 3602 ofdelivery device 3600 and implant 3800 into the atrium, delivery device3600 may be actuated to distally extend extension member 3606 relativeto delivery catheter 3604, thereby enabling deployment and expansion ofimplant 3800. Following deployment and expansion, extension member 3606may be at least partially retracted relative to delivery catheter 3604,resulting in the retracted/de-extended configuration of FIG. 45B. In atleast certain implementations, extension member 3606 may be configuredto undergo from and including about 15 mm to and including about 25 mmof travel relative to delivery catheter 3604 with possibleretraction/de-extension from and including about 50% to and includingabout 80% of the total travel distance of extension member 3606. Forexample, in one specific implementation, extension member 3606 may beconfigured to have approximately 20 mm of total travel with at least 12mm of retraction/de-extension available following deployment of implant3800.

FIG. 55 is a photograph of a portion of a deployment control assembly5500 illustrating an example implementation of extension/de-extensioncontrols that may be used in conjunction with delivery device 3600.Deployment control assembly 5500 includes an extension handle 5502 whichcan be rotated to extend and retract extension member 3606; however,extension handle 5502 may be substituted with a lever, slide, knob, orsimilar control element in other implementations.

XIV. Control Arm Assembly and Cinch Line Routing

As previously discussed, control arm assembly 3608 enables selectiveexpansion and collapse of implant 3800 during deployment andimplantation of implant 3800. To do so, control arm assembly 3608includes multiple control arm pairs with each control arm pair includinga proximal arm and a distal arm. Each proximal arm is shaped, biased,diverted, or otherwise configured such that when the proximal armextends distally from delivery catheter 3604 the proximal at leastpartially extends in a lateral/medial direction relative to longitudinalaxis 3603 of delivery device 3600. A distal portion of each proximal armis coupled to a proximal portion of its respective distal arm such thatthe distal arm similarly extends in a lateral/medial direction based onthe degree of extension of the proximal arm. The distal arm generallyprovides support and stability to the proximal arm; however, in certainimplementations, the proximal portion of the distal arm may also includea ring, a loop, an aperture, or similar feature through which cinch line3614 may pass to couple implant 3800 to delivery device 3600.

FIGS. 56 and 57 illustrate distal portion 3602 of delivery device 3600with control arm assembly 3608 in a collapsed and expanded state,respectively. The following discussion describes operation of controlarm assembly 3608 by referring primarily to proximal arm 3634 and distalarm 3640. Such references are intended for clarity and conciseness only.Unless otherwise specified, references to proximal arm 3634 and distalarm 3640 should be considered to apply generally to the other proximaland distal arms of control arm assembly 3608.

As illustrated in FIG. 56 , when in the collapsed state, proximal arm3634 and distal arm 3640 lie substantially flat and parallel tolongitudinal axis 3603 of delivery device 3600. As control arm assembly3608 is expanded, e.g., by pushing proximal portion 3630 of control armassembly 3608 with control arm shaft 3642 as discussed in the context ofFIGS. 42 and 43 , distal portion 3636 of proximal arm 3634 travels in apartially lateral direction. In certain implementations, lateral travelof distal portion 3636 results from proximal arm 3634 having a shape orbeing biased in an outwardly curved direction. Alternatively, or inaddition, delivery device 3600 may include a diverter or similarstructural element (such as diverter 3628 illustrated in FIG. 41 ) thatdirects proximal arm 3634 in a lateral direction as proximal arm 3634extends from delivery catheter 3604, as shown in FIG. 57 .

Due to the coupling of distal portion 3636 of proximal arm 3634 with aproximal portion 3641 of distal arm 3640, extension of proximal arm 3634from delivery catheter 3604 applies a lateral force to proximal portion3641 of distal arm 3640. In the implementation shown in FIGS. 56 and 57, a distal portion 3643 of distal arm 3640 is fixed to distal cap 3638of extension member 3606. Accordingly, as a lateral force is applied toproximal portion 3641 of distal arm 3640, distal portion 3643 of distalarm 3640 bends outwardly. In other implementations, distal arm 3640 mayinstead be coupled to distal cap 3638 by a hinge or similar movablejoint that permits lateral movement of proximal portion 3641 of distalarm 3640 without substantial bending.

Collapse of control arm assembly 3608 may be achieved by retractingproximal portion 3630 of control arm assembly 3608, which in turn causesretraction of proximal arm 3634 into delivery catheter 3604. Due againto the coupling of distal portion 3636 of proximal arm 3634 with aproximal portion 3641 of distal arm 3640, retraction of proximal arm3634 into delivery catheter 3604 applies a medial force to proximalportion 3641 or distal arm 3640, thereby causing distal arm 3640 toreturn to a collapsed configuration.

FIG. 58 illustrates an example coupling arrangement of proximal arm 3634with distal arm 3640 in further detail. As illustrated, distal portion3636 of proximal arm 3634 may include a first feature, e.g., aprotrusion 3637, shaped to be inserted into and retained by a secondfeature, e.g., an aperture 3639 of distal arm 3640. For example, FIG. 58shows protrusion 3637 as being T-, dogbone-, or barbell-shaped andaperture 3639 as an ovate slot. Accordingly, protrusion 3637 may berotated 90 degrees, inserted through aperture 3639, and unrotated tocause protrusion 3637 to be retained by aperture 3639 and couplingdistal portion 3636 to distal arm 3640. In other implementations, theprotrusion and aperture may be reversed such that a protrusion of distalarm 3640 extends through and is retained by an aperture of proximal arm3634. This disclosure contemplates other coupling arrangements ofproximal arm 3634 with distal arm 3640 and notes that any coupling thatpermits the necessary movement of proximal arm 3634 relative to distalarm 3640 for expansion of control arm assembly 3608 may be used insteadof the specific coupling arrangement illustrated in FIG. 58 .

FIG. 59 is a detailed view of coupling between control arm assembly 3608and implant 3800. As previously discussed, coupling of delivery device3600 to implant 3800 is by cinch line 3614, which forms a loop throughdelivery device 3600 and about an inner circumference of implant 3800.More specifically, cinch line 3614 extends through delivery catheter3604 (e.g., through cinch line tube 3620). Cinch line 3614 is thenrouted through apertures extending around each of control arm assembly3608 and implant 3800. Cinch line 3614 is then rerouted back throughdelivery catheter 3604 (e.g., through cinch line tube 3622) to aproximal end of delivery catheter 3604.

In certain implementations, the apertures of implant 3800 may be in theform of hoops, loops, or rings (e.g., ring 3804) extending around aninner surface 3802 of implant 3800. The apertures of control armassembly 3608 may similarly be in the form of hoops, loops, or rings(e.g., ring 3646) coupled to control arm assembly 3608. For example, inthe implementation of FIG. 58 , ring 3646 is attached to and extendsfrom proximal portion 3641 of distal arm 3640. In other implementations,distal arm 3640 or distal portion 3636 may define and include anintegrally formed hole, port, or similar opening that functions as theaperture through which cinch line 3614 extends.

By routing cinch line 3614 through each of the apertures of control armassembly 3608 and each of the apertures of implant 3800, implant 3800can be coupled to delivery device 3600. Additionally, such anarrangement also enables cinch line 3614 to provide additional controland uniformity when expanding and collapsing implant 3800 duringdeployment and implantation. For example, given that cinch line 3614extends around the circumference of implant 3800, applying tension tocinch line 3614 results in a distributed medial pulling force aboutimplant 3800. As implant 3800 is collapsed, this distributed medialforce encourages implant 3800 to collapse uniformly, thereby improvingcontrol and predictability during collapse of implant 3800. Thedistributed medial force may also act as a counterforce when expandingimplant 3800, which, again, encourages implant 3800 to expand uniformlyand improving control and predictability of implant expansion.

In certain implementations of this disclosure, delivery device 3600 mayinclude a control assembly including control elements for adjustingexpansion and collapse of control arm assembly 3608 and operation ofcinch line 3614. Referring back to FIG. 55 , for example, deploymentcontrol assembly 5500 includes an expansion handle 5504 that can berotated to selectively expand and collapse implant 3800 when implant3800 is coupled to control arm assembly 3608. For example, rotation ofexpansion handle 5504 may translate control arm shaft 3642 relative todelivery catheter 3604. As previously noted, such translation may pushor pull proximal portion 3630 of control arm assembly 3608, therebycausing expansion of control arm assembly 3608. In otherimplementations, expansion handle 5504 may be replaced with othercontrol elements, such as a lever, knob, or similar component forselectively translating control arm shaft 3642 relative to deliverycatheter 3604.

Deployment control assembly 5500 further includes a tensioner 5506 forcontrolling tension on cinch line 3614. When assembled, tensioner 5506couples to a first end of cinch line 3614 while a second end of cinchline 3614 may be fixed at another point on deployment control assembly5500. Tensioner 5506 may be selectively movable, e.g., along a rail5508, such that by proximally translating tensioner 5506, tension oncinch line 3614 can be increased. Conversely, by distally translatingtensioner 5506, tension can be reduced.

In at least certain implementations, implant 3800 is released fromdelivery device 3600 by cutting cinch line 3614 at deployment controlassembly 5500 and subsequently pulling cinch line 3614 from deliverycatheter 3604.

XV. Control Assembly and Mounting

Previous sections of this disclosure describe alternative configurationsfor a control assembly of delivery device 3600. In general, such controlassemblies provide various control elements for actuating variouscomponents of delivery device 3600. Among other things, such controlelements include those for extending and retracting sheath 3616,steering delivery catheter 3604, extending and retracting extensionmember 3606, expanding and collapsing control arm assembly 3608, andcontrolling tension on cinch line 3614.

FIG. 60 is a photograph illustrating a proximal portion of deliverydevice 3600 and, in particular, a control assembly 6000 of deliverydevice 3600. As shown, control assembly 6000 combines various controlassembly sections previously discussed in this disclosure. For example,control assembly 6000 combines (from most distal to most proximal) eachof sheath control assembly 5200, steering control assembly 4600, anddeployment control assembly 5500. Notably, control assembly 6000 isintended only as an example control assembly for use with deliverydevices according to this disclosure and that provides various functionsfor delivering, deploying, and implanting valve repair implants. Whilenot specifically illustrated other implementations of control assembliesmay include alternative arrangements of control assembly sections andadditional structural elements (e.g., an outer housing, grips, etc.),among other things.

FIG. 61 is a photograph illustrating an example mounting arrangement fordelivery device 3600, including control assembly 6000. In the exampleconfiguration, control assembly 6000 is received within a mount 6050coupled to and supported by a rail 6052. Rail 6052, in turn, is coupledto an articulating arm 6060, which may be fixed to a bed, table, supportstand, or similar stable structure.

Although other mounting configurations are contemplated, theconfiguration illustrated in FIG. 61 is advantageous in that it providestwo additional degrees of freedom for delivery device 3600. First, mount6050 includes a rotating cradle 6054 that receives delivery device 3600.Second, mount 6050 is coupled to rail 6052 by a stepper-type mount suchthat insertion of delivery device 3600 is controllable by a knob 6056.Mount 6050 may further include additional controls for locking each ofrotating cradle 6054 and the position of mount 6050 on rail 6052.

XVI. Example Implantation Process

To provide additional detail and context for the various featuresdescribed in the preceding sections, FIG. 62 is a block diagramillustrating a method 6200 for implanting implant 3800 using deliverydevice 3600.

At step 6202, implant 3800 is delivered to a patient atrium, e.g., viaan antegrade percutaneous route (e.g., a trans-femoral or trans-jugularroute). During delivery, implant 3800 is coupled to a distal end ofdelivery device 3600 by cinch line 3614 with sheath 3616 extending overa distal end of delivery device 3600, including at least a portion ofimplant 3800. As previously discussed, coupling of implant 3800 todelivery device 3600 may include routing cinch line 3614 through a firstset of apertures disposed around an interior circumference of implant3800, such as a series of loops or rings distributed about the interiorcircumference of implant 3800. Cinch line 3614 is further routed througha second set of apertures of control arm assembly 3608, thereby couplingimplant 3800 to control arm assembly 3608 using cinch line 3614. In atleast some implementations, the apertures of control arm assembly 3608may be rings coupled to proximal portions of the distal control arms ofcontrol arm assembly 3608. For example, FIG. 59 shows ring 3646 coupledto proximal portion 3641 of distal arm 3640.

In at least some implementations, navigating delivery device 3600 andimplant 3800 to the implantation site may include routing deliverydevice 3600 along a guidewire previously inserted into the patient andextending to the atrium.

Step 6204 includes retracting sheath 3616 to facilitate subsequentdeployment of implant 3800. As discussed in previous sections,retracting sheath 3616 may include manipulating a control of controlassembly 6000 to proximally translate sheath 3616 relative to deliverycatheter 3604.

Step 6206 includes deploying implant 3800. Deploying implant 3800generally refers to the process of clearing implant 3800 from sheath3616 and delivery catheter 3604 such that implant 3800 can be freelyexpanded, collapsed, and positioned for implantation. Deploying implant3800 may include partially expanding implant 3800, e.g., by expandingcontrol arm assembly 3608. For example, a user may partially expandcontrol arm assembly 3608 by rotating a corresponding handle or knob ofcontrol assembly 6000. Deploying implant 3800 may also include at leastpartially extending implant 3800 distally relative to delivery catheter3604. In at least some implementations, extending implant 3800 mayinclude distally extending extension member 3606 relative to deliverycatheter 3604 using a corresponding control of control assembly 6000.

Step 6208 includes retracting/de-extending implant 3800 relative todelivery catheter 3604 following at least partial expansion of implant3800. As previously discussed, in certain implementations, initialdeployment of implant 3800 may require that implant 3800 extend to afirst distal extent beyond delivery catheter 3604, e.g., to permitclearance of implant 3800 from sheath 3616 and delivery catheter 3604.Once deployed, however, implant 3800 may be longitudinallyretracted/de-extended to make the combination of the distal portion ofdelivery device 3600 and implant 3800 more compact. Among other things,the more compact configuration improves maneuverability of implant 3800within the heart, thereby increasing the speed and accuracy with whichimplant 3800 can be positioned and implanted.

Step 6210 includes positioning implant 3800 for implantation. In atleast certain implementations, positioning implant 3800 may includepositioning implant 3800 such that an occlusive element of implant 3800is at the level of the native leaflets or otherwise positioned tocontact and interact with the native leaflets. During certainprocedures, positioning implant 3800 may also include additionalexpanding, collapsing, and/or moving of implant 3800 to achieve properpositioning. Accordingly, step 6210 may include one or more ofexpanding/collapsing control arm assembly 3608, extending/retractingextension member 3606, steering delivery catheter 3604, or any otherarticulation of delivery device 3600 necessary to properly positionimplant 3800 within the heart.

Step 6212 includes fully expanding implant 3800 once implant 3800 is inposition for implantation. Fully expanding implant 3800 may includeexpanding control arm assembly 3608 to or near its fullest extent.Notably, in most applications and when implant 3800 is properlypositioned relative to the cardiac valve, such expansion will causeimplant 3800 to interfere with and engage cardiac tissue. For example,implant 3800 may include outwardly protruding prongs shaped andpositioned to engage tissue adjacent the valve.

Step 6214 includes releasing implant 3800 from delivery device 3600.Releasing implant 3800 from delivery device 3600 includes decouplingimplant 3800 from delivery device 3600 by removing cinch line 3614. Forexample, cinch line 3614 may be cut at control assembly 6000 andsubsequently pulled from delivery device 3600. During pulling, the cutend of cinch line 3614 passes through the apertures of control armassembly 3608 and implant 3800, resulting in implant 3800 beingdecoupled from control arm assembly 3608.

Step 6216 includes preparing delivery device 3600 for retraction andremoval from the patient. In general, preparation of delivery device3600 includes collapsing delivery device 3600 to its fullest extent andsheathing distal portion 3602 of delivery device 3600. For example,preparing delivery device 3600 for retraction may include fullycollapsing control arm assembly 3608, retracting/de-extending extensionmember 3606, and re-extending cinch line 3614 over the distal end ofdelivery device 3600.

Step 6218 includes retracting delivery catheter 3604 from the patient,substantially completing the implantation process.

XVII. Additional Alternative Implant and Occluder Designs

FIGS. 63A-64N illustrate an implant 6300 according to anotherimplementation of the present disclosure. Specifically, FIG. 63A is aperspective proximal-side (atrial-side when implanted) view of implant6300 while FIGS. 63B and 63C are perspective and plan views of a distalside of implant 6300, respectively. FIG. 63D is the same as FIG. 63Calbeit with various dimensions indicated. FIGS. 64A-64P illustrate aframe 6355 of implant 6300 and various details of frame 6355. FIGS.63A-63C illustrate implant 6300 in an expanded state, such as whenimplant 6300 is implanted in a cardiac valve to be repaired.

As illustrated in FIGS. 63A-63D, implant 6300 generally includes adistal end 6340 and a proximal end 6345. Distal end 6340 serves as theleading end of implant 6300 during implantation and is directed towardthe ventricle following implantation within the valve annulus. Implant6300 further includes an occluder 6302 disposed at distal end 6340.Occluder 6302 is coupled to and supported on frame 6355 . In contrast toprevious occluders disclosed herein, which included bulb-type occluders(including those with sheet-style skirts) and sheet-type occluders,occluder 6302 is a cap-style occluder formed by laminating multiplesheets of material about a distal portion of frame 6355. Implant 6300further includes an outer sheet 6360 supported by frame 6355. When inthe expanded state, frame 6355 radiates laterally outward relative to acentral longitudinal axis 6370 (indicated in FIGS. 63A and 63B) ofimplant 6300 with occluder 6302 forming a distal surface 6361 and outersheet 6360 forming an annular surface 6364. Further details regardingoccluder 6302 and outer sheet 6360 are illustrated and discussed belowin the context of FIGS. 65A-65F for occluder 6302 and FIG. 66A-67 ,respectively.

Distal surface 6361 formed by occluder 6302 includes a proximal radiallyoutward edge 6363 while annular surface 6364 of outer sheet 6360 formseach of a distal radially inward edge 6365 and a proximal radiallyoutward edge 6366. Proximal radially outward edge 6363 of distal surface6361 and distal radially inward edge 6365 of annular surface 6364 definean opening 6367 between occluder 6302 and outer sheet 6360.

As with previous implants of this disclosure, implant 6300 may betransitioned into a collapsed state for delivery to the targetimplantation site. When collapsed, frame 6355, occluder 6302, and outersheet 6360 may collapse symmetrically about central longitudinal axis6370. Also, like previous implants of this disclosure, frame 6355 may bebiased into expansion such that implant 6300 self-expands into theexpanded state, e.g., to anchor itself within the target cardiac valveannulus.

Each of occluder 6302 and outer sheet 6360 are supported on frame 6355.In the specific example shown, occluder 6302 is coupled to and supportedon frame 6355 by a bonding and lamination process. More specifically, atleast one first layer of occluder 6302 is disposed on a distal surfaceof 6355 while at least one second layer of occluder 6302 is disposed ona proximal surface of frame 6355. Subsequent bonding of the layers(e.g., by application of an epoxy or other adhesive, heating, etc.)simultaneously forms occluder 6302 and couples occluder 6302 to frame6355. In contrast, outer sheet 6360 is illustrated as being coupled toframe 6355 by sutures extending along distal radially inward edge 6365,proximal radially outward edge 6366, and frame 6355. Each of thelamination of occluder 6302 and the suturing of outer sheet 6360 toframe 6355 is described below in further details.

Implementations of this disclosure are not strictly limited toparticular sizes or dimensions and may be modified or customized to meetthe needs of patients and specific applications. Nevertheless, andwithout limitation to the scope of this disclosure, certain specificexamples of dimensions are provided and indicated in FIG. 63D.

In certain implementations, occluder 6302 may have a diameter (D1) fromand including about 16 mm to and including about 28 mm, with the maximumdiameter generally corresponding to the diameter of occluder 6302 Forexample, occluder 6302 may a maximum diameter of about 22 mm.

In other implementations, outer sheet 6360 may have an inner diameter(D2) (e.g., the diameter of distal radially inward edge 6365) from andincluding about 36 mm to and including about 46 mm. For example, distalradially inward edge 6365 may have a diameter of about 41 mm.

As shown in FIG. 63D, each of outer sheet 6360 and frame 6355 may have asinusoidal or otherwise varying proximal edge. In such implementations,proximal radially outward edge 6363 may be defined by each of a minimumdiameter (D3) and a maximum diameter (D4). Among other things, a varyingproximal edge balances robust anchoring of the implant within the valveannulus with reduced interference of the implant with native cardiacstructures. More specifically, a sinusoidal proximal edge of frame 6355and outer sheet 6360 provides robust anchoring and support by allowingframe 6355 to extend onto and to be distributed over a wider area aboutthe valve annulus. In contrast, the sinusoidal edge of frame 6355reduces the proximal portion of outer sheet 6360 as compared to similarconfigurations with the same maximum diameter but a circular proximaledge, thereby reducing the potential for interference between implant6300 and other cardiac structures.

With the foregoing in mind, in at least certain implementations, theminimum diameter of proximal radially outward edge 6363 (D3) may be fromand including about 48 mm to and including about 68 mm. For example, theminimum diameter of proximal radially outward edge 6363 may beapproximately 58 mm. Similarly, the maximum diameter of proximalradially outward edge 6363 (D4) may be from and including about 58 mm toand including about 78 mm, but at least as large as the minimum diameterof proximal radially outward edge 6363. For example, in one specificexample, the maximum diameter of proximal radially outward edge 6363 maybe about 68 mm.

While this disclosure notes that a sinusoidal or varying configurationfor proximal radially outward edge 6363 provides certain advantages,such a configuration is not necessary and implementations of thisdisclosure are not limited to configurations in which proximal radiallyoutward edge 6363 varies. Accordingly, while not specificallyillustrated in the context of implant 6300, this disclosure alsocontemplates that proximal radially outward edge 6363 of implant 6300may be of constant diameter/circular.

While the height of implant 6300 is generally defined as the distancebetween distal extent 6375 and the proximal extent of proximal radiallyoutward edge 6363. Like other aspects of implant 6300, the height ofimplant 6300 may vary, e.g., to accommodate variations in patientanatomy. In at least certain implementations, however, the overallheight of implant 6300 may be from and including about 15 mm to andincluding about 25 mm. For example, the overall height of implant 6300may be approximately 20 mm.

Further details regarding the construction of implant 6300 are providedwith reference to FIGS. 64A-M, which illustrate frame 6355 in detail.More specifically, FIG. 64A is a distal isometric view of frame 6355,FIG. 64B is a distal elevation view of frame 6355, and FIG. 64C is anelevation view of frame 6355. FIGS. 64D and 64E are views of frame 6355indicating specific features and elements of interest. FIGS. 64F-64K aredetailed views of those features. FIG. 64L and FIG. 64M areside/elevation views of frame 6355 while FIG. 64N is a detailed view ofa single spoke of frame 6355.

Referring first to FIGS. 64A-C, frame 6355 includes distal frame portion6358, which supports occluder 6302 when fully assembled, and a proximalframe portion 6359, which supports outer sheet 6360. In general, each ofdistal frame portion 6358 and proximal frame portion 6359 include a setof circumferentially distributed petal portions configured to collapseand expand as implant 6300 is similarly collapsed and expanded duringdelivery and implantation.

While this disclosure contemplates that frame 6355 may be manufacturedand assembled in various ways, in at least certain implementations,frame 6355 is formed as a unitary component by precision cutting atubular substrate of material suitable for use in medical implants. Forexample, in at least certain implementations, frame 6355 is cut fromhigh-cycle fatigue (HCF) nitinol tubing. The frame, as cut from thetubing, may be subsequently heated and bent into the final shapeillustrated in the figures and described in the following section usinga shape setting process consistent with the substrate material.Subsequent processing of the frame, such as electropolishing,passivation, deburring, cleaning, and the like, may also be applied toachieve the finished frame product.

As most clearly shown in FIG. 64B, distal frame portion 6358 may includeradially extending and circumferentially distributed inner petalportions, such as inner petal portion 6380A and inner petal portion6380B. The inner arcuate petal portions may be ovate, diamond-shaped, orotherwise have a similar elongate shape (e.g., generally diamond shapedalbeit with rounded vertices and/or curved edges). Each inner petalportion may be defined by respective major and minor axes. For example,as shown in FIG. 64J, inner petal portion 6380A has a major axis 6381Athat extends in a radial/longitudinal direction and a minor axis 6382Athat extends in a substantially circumferential direction. In certainimplementations, adjacent inner petal portions may be joined at or nearthe vertices along the minor axis. For example, and as indicated in FIG.64J, inner petal portion 6380A and inner petal portion 6380B are joinedat a junction 6384 disposed distal minor axis vertices of inner petalportion 6380A and inner petal portion 6380B.

Referring to FIG. 64B, proximal frame portion 6359 may similarly includeouter petal portions that may be ovate, diamond-shaped, or have anotherelongate shape. Each such outer petal portion may be defined byrespective major and minor axes. For example, and as shown in FIG. 64K,outer petal portion 6385A may have a major axis 6386A that extends in asubstantially longitudinal direction and a minor axis 6387A that extendsin a circumferential direction. In certain implementations, adjacentouter petal portions of proximal frame portion 6359 may be joined at ornear the vertices along the minor axis (i.e., the co-vertices of theouter petal portions). For example, outer petal portion 6385A and outerpetal portion 6385B are joined at a junction 6389 disposed at thecorresponding co-vertices of outer petal portion 6385A and outer petalportion 6385B.

Referring back to FIG. 64B, frame 6355 generally includes members,struts, spokes, or similar elongate members. When frame 6355 is in acollapsed state, the spokes extend in a substantially longitudinaldirection; however, as frame 6355 expands, the spokes/struts extendradially outward as well as proximally. As shown in FIG. 64B, aspoke/strut extends from each of the arcuate petal portions of thedistal frame portion 6358 and, more specifically, from the proximalvertex of each of arcuate petal portion. For example, FIGS. 64B and 64Jillustrate each of a spoke 6395A extending from a vertex 6396A of innerpetal portion 6380A and a spoke 6395B extending from vertex 6396B ofinner petal portion 6380B.

Referring again to FIG. 64B, each spoke extends from its correspondinginner petal portion of distal frame portion 6358 to a respectivejunction between outer arcuate petal portions of the proximal frameportion 6359. For example, FIG. 64M illustrates spoke 6395C terminatingat junction 6389 between outer petal portion 6385A and outer petalportion 6385B.

Each spoke may further extend to form an anchor member (e.g., a spike,tine, or hook) disposed between adjacent outer petal portions. Forexample, each of FIGS. 64B and 64M include anchor member 6399 disposedbetween outer petal portion 6385A and outer petal portion 6385B andextending from junction 6389. As illustrated, anchor members areincluded between each pair of adjacent outer petal portions; however,this disclosure contemplates that more or fewer anchor members may beincluded and the distribution of anchor members about frame 6355 mayvary. For example, in addition to anchor members disposed betweenadjacent outer petal portions, additional anchor members may extend fromthe distal vertex of one of more of the outer petal portions. As anothernon-limiting alternative, anchor members may extend from every other orevery third junction between adjacent outer petal portions.

FIGS. 64D and 64E are views of frame 6355 indicating specific featuresand elements of interest, which are shown in detail in subsequent FIG.64F-641 . More specifically, FIG. 64D is a side elevation view of frame6355 with frame 6355 oriented with a spoke/anchor member directedoutward from the figure. In contrast, FIG. 64E is an angled side view offrame 6355 with frame 6355 oriented with an outer petal portion directedoutward from the figure (i.e., at a 90-degree rotation relative to theview shown in FIG. 64D). As shown in FIG. 64D, FIG. 64F is a sideelevation view of a portion of frame 6355 and, in particular, a detailedview of a spoke section 6400 extending that generally extends between aninner petal portion of frame 6355 and a junction between adjacent outerpetal portions. For example, spoke section 6400 may correspond tosections of spoke 6395A and spoke 6395B extending between the innerpetal portions of frame 6355 and their corresponding junctions of outerpetal portions. The specific curvature of spoke section 6400 isdiscussed below in further detail in the context of FIGS. 64N-P.However, as shown in FIG. 64F, spoke section 6400 has a generallydistally convex curvature. While the specific dimensions of spokesection 6400 may vary, in at least some implementations, spoke section6400 may have a thickness 6402 from and including about 0.2 mm to andincluding about 0.4 mm. For example, in one specific implementation,thickness 6402 may be about 0.32 mm with a tolerance of +/- 0.04 mm. Inimplementations in which frame 6355 is formed by cutting frame 6355 froma tubular substrate, thickness 6402 may correspond to the thickness ofthe tubular substrate.

As further shown in FIG. 64D, FIG. 64G is a side elevation view of ananchor member 6404 of frame 6355. For example, anchor member 6404 maycorrespond to anchor member 6399 of frame 6355 or any other anchormember distributed about frame 6355. As previously discussed, anchormembers of implants according to this disclosure are generallyconfigured to engage tissue surrounding the valve annulus to facilitateanchoring of the implant relative to the valve annulus duringimplantation. The specific size, shape, angle, and similarcharacteristics of anchor member 6404 may vary based on the application;however, FIG. 64G illustrates one non-limiting example configuration ofanchor member 6404 that has demonstrated positive results in testing. Asillustrated, anchor member 6404 extends from a junction 6406, which, aspreviously discussed, is generally located between adjacent outer petalportions. For example, junction 6389 of frame 6355 is shown in FIG. 64Bas being located between outer petal portion 6385A and outer petalportion 6385B. As shown, anchor member 6404 may be integral withjunction 6406 and may be formed by distally bending or curving anchormember 6404.

The performance characteristics of anchor member 6404 can be varied andcontrolled by modifying the geometry of anchor member 6404 and itsgeometric relationship (e.g., angle) relative to the other portions of6355. For example, FIG. 64G indicates a depth 6408 or linear distance ofanchor member 6404, which generally corresponds to a maximum lineardistance between a tip 6410 of anchor member 6404 and the outer surfaceof a junction 6406 between adjacent outer petal portions (e.g., junction6389 between outer petal portion 6385A and outer petal portion 6385B).While depth 6408 may vary, in at least some implementations, depth 6408may be from about 1.0 mm to 3.5 mm. For example, in one specificimplementation, depth 6408 may be about 2.2 mm with a tolerance of+/-0.4 mm.

Performance characteristics of anchor member 6404 can also be varied andcontrolled by modifying a thickness 6412 of anchor member 6404. Whilethickness 6412 may vary, in at least some implementation, thickness 6412may be from and including about 0.2 mm to and including about 0.4 mm.For example, thickness 6412 may be about 0.32 mm with a tolerance of +/-0.04 mm. In implementations in which frame 6355 is formed by cuttingframe 6355 from a tubular substrate, thickness 6412 may correspond tothe thickness of the tubular substrate.

As indicated in FIG. 64E, FIGS. 64H and 641 are detailed views ofrespective outer petal portions and, specifically, proximal extents ofthe outer petal portions. More specifically, FIG. 64H illustrates anouter petal portion 6414 and, specifically, a detailed front view of aproximal chevron 6416 of outer petal portion 6414. FIG. 641 , incontrast, illustrates an outer petal portion 6424 and, in particular, adetailed side view of a proximal chevron 6426 of outer petal portion6424.

Referring first to FIG. 64H, proximal chevron 6416 is formed at thejunction of two petal sections, namely, petal section 6420A and petalsection 6420B. As previously noted, in certain implementations of thisdisclosure, frame 6355 is laser cut from a tubular substrate such thatcertain dimensions may be controlled or otherwise dictated by the wallthickness of the tubular substrate. In contrast, when frame 6355 is cutfrom a tubular substrate, the width of petal section 6420A and petalsection 6420B generally correspond to circumferential lengths of thetubular substrate and, as a result, are controlled and dictated by cutsmade to the tubular substrate. Stated differently, the width of petalsection 6420A and petal section 6420B can be varied and controlled andare not necessarily limited to any specific dimensions of the tubularsubstrate from which frame 6355 is cut. For example, FIG. 64Hillustrates a width 6422 of each of petal section 6420A and petalsection 6420B. While width 6422 may vary, in at least certainimplementations, width 6422 may be from and including about 0.2 mm toand including about 0.4 mm. For example, in one specific implementation,width 6422 may be 0.32 mm with a tolerance of +/- 0/04 mm.

Referring next to FIG. 64I, proximal chevron 6426 of outer petal portion6424 is formed at the junction of two petal sections, namely, petalsection 6428A and petal section 6428B, each of which generally has athickness 6430. In certain implementations thickness 6430 ay becontrolled by or otherwise correspond to a wall thickness of a tubularsubstrate from which frame 6355 is cut. Thickness 6430 may vary;however, in at least certain implementations, thickness 6430 may be fromand including about 0.2 mm to and including about 0.4 mm. For example,thickness 6412 may be about 0.32 mm with a tolerance of +/- 0.04 mm.

Like previous frames discussed herein, frame 6355 may be formed from avariety of superelastic and/or shape memory materials, including, forexample, nickel-titanium alloys (e.g., Nitinol), which may be laser cutfrom a tube or in the form of drawn wire. The features defined in theshape memory materials may be defined therein via various cuttingmethods known in the art, include laser, water jet, electrical dischargemachining (EDM), stamping, etching, milling, etc.

While illustrated as including 12 each of outer arcuate petal portionsand inner arcuate petal portions, in other implementations, frame 6355may include different numbers of inner and/or outer arcuate petalportions. For example, in certain example embodiments, frame 6355 mayinclude between 10 and 14, between 8 and 16, or between 6 and 18 innerand outer arcuate petal portions. In other implementations, the numberof inner arcuate petal portions may differ from the number of outerarcuate petal portions. Moreover, not every inner arcuate petal portionmay be coupled to a corresponding spoke of frame 6355. For example,spokes may extend from only every other of inner arcuate petal portions.

As shown in the preceding figures, each inner arcuate petal portion isunform as is each outer arcuate petal portion. In other implementations,the inner and outer arcuate petal portions may vary in any direction.For example, the inner arcuate petal portions may alternate betweenarcuate petal portions having a first major axis dimension and arcuatepetal portions have a second major axis dimension different than thefirst major axis dimension.

Additional examples dimensions and features of frame 6355 are indicatedin FIGS. 64L-64N. Specifically, FIGS. 64L and 64M are additional sideviews of frame 6355 with FIG. 64M being the view of FIG. 64L rotatedapproximately 90 degrees about the longitudinal axis 6370 of frame 6355.FIG. 63N is a detailed view of an example spoke 6432. The followingdiscussion describes various dimensions and shapes of frame 6355 and itselements. As with other aspects of this disclosure, any specificdimensions and values should be considered non-limiting and are merelyincluded as example values found to be suitable for use in certain valverepair procedures. Among other things, the dimensions described belowmay be modified and adjusted to account for differences in patientphysiology.

Referring first to FIG. 64L, frame 6355 is shown with three dimensionsindicated and generally related to the spokes and inner petal portionsof frame 6355. First, overall height of frame 6355 is indicated as H1.In general, H1 corresponds to the distance between a distal and proximalextent of frame 6355 along central longitudinal axis 6370. In certainimplementations and without limitation, H1 may be from and includingabout 15 mm to and including about 20 mm and, in one specific examplemay be approximately 17.5 mm with a tolerance of +/- 0.5 mm.

FIG. 64L further includes dimension H2, which corresponds tolongitudinal height of the outer petal portions as measured from theproximal extend of frame 6355. In certain implementations and withoutlimitation, H2 may be from and including about 11 mm to and includingabout 16 mm and, in one specific example may be approximately 14 mm witha tolerance of +/- 0.5 mm.

Finally, FIG. 64L includes dimension R1, which corresponds to a radiusof curvature of the outer petal portions. In certain implementations andwithout limitation, R1 may be from and including about 15 mm to andincluding about 35 mm and, in one specific example may be approximately25 mm.

Turning to FIG. 64M, frame 6355 is shown with two dimensions indicated.First, the height of the anchor members of frame 6355 relative to thedistal extent of frame 6355 is indicated as H3. In certainimplementations and without limitation, H3 may be from and includingabout 9 mm to and including about 15 mm and, in one specific example maybe approximately 12 mm.

FIG. 64M further includes the height of the inner petal portionsrelative to the distal extent of frame 6355, which is indicated as H4.In certain implementations and without limitation, H4 may be from andincluding about 1.5 mm to and including about 3.5 mm and, in onespecific example may be approximately 2.4 mm.

FIG. 64N is a cross-sectional view of frame 6355 focusing on a member6432 of frame 6355 and with the remaining elements of frame 6355 removedfor clarify. As indicated, member 6432 includes an anchor member 6434, ajunction section 6436 (which corresponds to junctions between outerpetal portions of frame 6355), a spoke 6438, and an inner petal portion6440. FIG. 64N includes indicators for two curvatures and five heightdimensions. As with the previous figures, the various dimensions areintended to be merely illustrative and can be readily adapted andmodified, e.g., to accommodate differences in patient physiology.

Dimension H5 corresponds to a height of anchor member 6434 and junctionsection 6436. In certain implementations and without limitation, H5 maybe from and including about 1 mm to and including about 4 mm and, in onespecific example may be approximately 2 mm. Other example dimensions andcharacteristics of anchor member 6434 are provided above in the contextof FIG. 64G.

Dimension H6 corresponds to a height of a proximally concave section6439 of spoke 6438. Proximally concave section 6439 generally extendsbetween junction section 6436 and a distally concave section 6441 ofspoke 6438. As shown, proximally concave section 6439 is generallydefined in FIG. 64N by a height H6 and a radius of curvature R2 with H6corresponding to a distance between junction section 6436 and a distalextent of proximally concave section 6439. In certain implementationsand without limitation, H6 may be from and including about 2 mm to andincluding about 4 mm and, in one specific example may be approximately 3mm. Similarly, in certain implementations and without limitation, R2 maybe from and including about 4 mm to and including about 10 mm and, inone specific example may be approximately 7 mm.

Dimension H7 corresponds to a difference between a distal extent ofproximally concave section 6439 and a proximal extent of distallyconcave section 6441. In certain implementations and without limitation,H7 may be from and including about 0.25 mm to and including about 3 mmand, in one specific example may be approximately 1.25 mm.

Dimension H8 corresponds to a height of distally concave section 6441.Distally concave section 6441 generally extends between proximallyconcave section 6439 and inner petal portion 6440. As shown, distallyconcave section 6441 is generally defined in FIG. 64N by a height H8 anda radius of curvature R3 with H8 corresponding to a distance between aproximal extent of distally concave section 6441 and the beginning ofinner petal portion 6440. In certain implementations and withoutlimitation, H8 may be from and including about 2.5 mm to and includingabout 8.5 mm and, in one specific example may be approximately 5.5 mm.Similarly, in certain implementations and without limitation, R3 may befrom and including about 4 mm to and including about 10 mm and, in onespecific example may be approximately 7 mm.

Finally, dimension H9 corresponds to a height of inner petal portion6440 and is generally defined as the distance between the end ofproximally concave section 6439 and the distal extent of frame 6355. Incertain implementations and without limitation, H9 may be from andincluding about 1.5 mm to and including about 4 mm and, in one specificexample may be approximately 2.5 mm. Similarly, in certainimplementations and without limitation, R4 may be from and includingabout 30 mm to and including about 50 mm and, in one specific examplemay be approximately 40 mm.

XVIII. Laminated Occluders for Valve Repair Implants

As previously discussed in the context of FIGS. 64A and 63B, implant6300 includes occluder 6302. In contrast to bulb- and sheet-styleoccluders of other implementations provided in this disclosure, occluder6302 has a multi-layered laminated structure and a general cap-likeshape. Among other things, such occluders result in a generally lowerprofile and smaller overall height of implant 6300 while forming arelatively large distal surface of implant 6300 against which the nativevalve leaflets can seal, providing substantial reduction inregurgitation and other valve-related issues.

FIGS. 65A and 65B are detailed views of occluder 6302 of implant 6300.More specifically, FIG. 65A is a distal view of occluder 6302 while FIG.65B is an isometric view of occluder 6302. FIG. 65C is a distalisometric view of frame 6355 and occluder 6302 of implant 6300 and isprovided to illustrate occluder 6302 in the broader context of implant6300 and frame 6355.

Referring to FIGS. 65A and 65B, occluder 6302 is generally formeddirectly onto distal frame portion 6358 of frame 6355. Morespecifically, occluder 6302 is formed onto the inner petal portions ofdistal frame portion 6358. While this disclosure contemplates thatoccluder 6302 may be formed onto distal frame portion 6358 in variousways, in at least one implementation, occluder 6302 is formed ontodistal frame portion 6358 by applying a first sheet 6502 ofsubstantially impervious material onto a distal surface 6504 (shown mostclearly in FIG. 65D) of distal frame portion 6358. A second sheet 6506of porous or semi-porous material is then disposed on a proximal surface6508 of distal frame portion 6358 such that second sheet 6506substantially overlaps first sheet 6502 with the inner petal portions ofdistal frame portion 6358 disposed between first sheet 6502 and secondsheet 6506. An epoxy, adhesive, or similar bonding material is thenapplied to proximal surface 6508 of distal frame portion 6358 such thatit penetrates second sheet 6506 and, once cured, bonds second sheet 6506to first sheet 6502 and the inner petal portions of distal frame portion6358.

FIG. 65D is an exploded view of occluder 6302 and frame 6355. As shown,each of first sheet 6502 and second sheet 6506 are cut and shaped to bereceived onto and bonded to distal frame portion 6358 of frame 6355. Thespecific materials and process for forming occluder 6302 may vary inimplementations of this disclosure; however, in at least one exampleimplementation, first sheet 6502 is formed from an engineering polymerthat is biocompatible and has low porosity. In certain implementations,for example, first sheet 6502 may be formed from expandedpolytetrafluoroethylene (ePTFE) or a similar polymer. Second sheet 6506,in contrast, may be formed from a substantially more porous and flexiblematerial. By way of non-limiting example, in certain implementationssecond sheet 6506 is formed from a porous and biocompatible fabric, suchas a woven polyethylene terephthalate (PET) material. For example, insome implementations, the material of second sheet 6506 may be the sameas or similar to that used for outer sheet 6360 of implant 6300 (shownin FIG. 63A).

While this disclosure contemplates that different materials may be usedto bond first sheet 6502 and second sheet 6506 to each other and todistal frame portion 6358, in one example implementation, bonding isachieved using a combination of a siloxane segmented polyurethane and apolymer precursor, such as tetrahydrofuran (THF). During assembly, thepolyurethane is solved in the THF and the resulting mixture is appliedto second sheet 6506 and proximal surface 6508 of distal frame portion6358 following layering of first sheet 6502 and second sheet 6506 ontodistal frame portion 6358. The relatively high viscosity of thepolyurethane/THF mixture allows for relatively easy penetration ofsecond sheet 6506, encapsulation of the fibers of second sheet 6506, andflow into the volume between first sheet 6502 and second sheet 6506containing distal frame portion 6358. Following subsequent curing, thepolyurethane/THF mixture provides a robust, consistent, andsubstantially impermeable bond between first sheet 6502 and second sheet6506. Notably, polyurethane and certain polyurethane-based compounds arecapable of curing/setting without application of additional heat whichmay cause frame 6355 to deform or lose shape.

FIGS. 65E and 65F are distal and side elevation views of frame 6355including occluder 6302 following bonding of occluder 6302 to frame6355. As shown in FIG. 65 and as previously discussed in the context ofFIG. 64D, occluder 6302 may generally have a diameter D1. While D1 mayvary in applications of the present disclosure, in certainimplementations, D1 may be from and including about 16 mm to andincluding about 28 mm. In other implementations, D1 may be from andincluding about 20 mm to and including about 22 mm. In one specificimplementation, D1 is about 21.4 mm with a tolerance of +/-0.5 mm.

Referring to FIG. 65F, occluder 6302 may also be constructed to have adefined height, as indicated by dimension H10. As shown, H10 generallycorresponds to the distance between a distal tip of occluder 6302 (whichgenerally corresponds to the distal extent of implant 6300) and aproximal edge of occluder 6302 (e.g., proximal radially outward edge6363 shown in FIGS. 63A and 64B). H10 may vary; however, in certainimplementations, H10 may be from and including about 3.0 mm to andincluding about 5 mm. For example, in one implementation H10 isapproximately 4 mm with a tolerance of +/-0.5 mm.

FIGS. 66A and 66B illustrate an occluder 6602 that may be used forimplant 6300 and other implants according to this disclosure as analternative or variation of occluder 6302. Specifically, FIG. 68A is adistal view of alternative occluder 6602 as coupled to frame 6355 ofimplant 6300 while FIG. 68B is a proximal view of occluder 6602 similarassembled as implant 6300.

As discussed above and illustrated in FIGS. 65A-65F, occluder 6302 has aconcave proximal surface. In contrast and as most clearly illustrated inFIG. 66B, occluder 6602 is configured to have a proximal surface 6604that is convex. Among other things, convex proximal surface 6604 canprovide benefits to hemodynamic flow across implant 6300 by moreeffectively directing flow around occluder 6602.

As shown in FIGS. 66A and 66B, occluder 6602 may have a multi-partconstruction including a distal section 6606 coupled to a proximalsection 6608. Distal section 6606 is distally concave and may besubstantially similar to occluder 6302. Proximal section 6608, incontrast, is distally concave and is coupled to distal section 6606 suchthat occluder 6602 has an overall pillow shape. As shown in FIGS. 66Aand 66B, proximal section 6608 is coupled to distal section 6606 bysuturing distal section 6606 to proximal section 6608; however, thisdisclosure contemplates that proximal section 6608 may be coupled todistal section 6606 using other methods, such as adhesives, epoxies,welding/bonding, and the like.

Proximal section 6608 may be constructed in various ways; however, inthe implementation shown in FIG. 68B, proximal section 6608 includes asheet 6610 and an internal frame 6612. Internal frame 6612 is shown ashaving a star-shaped construction including radially extending arms,such as arm 6614. Each arm is coupled to sheet 6610, e.g., by a suture,thereby attaching sheet 6610 to internal frame 6612 such that internalframe 6612 imparts a curved shape to sheet 6610. In at least certainimplementations, internal frame 6612 may be formed using techniquessimilar to those used in forming frame 6355. For example, internal frame6612 may be cut (e.g., laser cut) from tube-shaped substrate (e.g., anitinol tube), treated, and formed into the star-like shape shown inFIG. 68B.

Sheet 6610 may similarly be formed from various materials; however, incertain implementations, sheet 6610 may be formed from a porousmaterial, such as the woven PET used for second sheet 6506 of occluder6302 and outer sheet 6360 of implant 6300. Among other things, using aporous material allows an internal volume 6616 of occluder 6602 to beflushed of air in preparation for delivery and implantation. Followingimplantation, the porosity of sheet 6610 may permit some blood to flowinto internal volume 6616; however, sheet 6610 substantially limitsblood flow out of internal volume 6616, such that blood entering intointernal volume 6616 eventually fills and clots within internal volume6616, forming a thrombus that effectively results in occluder 6602having a substantially solid body that directs blood flow aroundoccluder 6602.

In certain alternative implementations, internal volume 6616 may befilled with an epoxy, solidifying gel, solid insert, or similar materialor object that substantially fills internal volume 6616 prior todelivery and implantation. In other implementation, internal volume 6616may contain a hydromorphic polymer, hydrogel, or similar substance thatexpands when exposed to a fluid, e.g., blood, such that the materialexpands to fill internal volume 6616 following implantation. In stillother alternative implementations, occluder 6602 may have asubstantially solid construction. For example, occluder 6602 may be inthe form of a substantially solid biocompatible body having an overallshape similar to that of occluder 6602 shown in FIGS. 66A and 66B andthat can be readily coupled to distal frame portion 6358 to formoccluder 6602.

XIX. Outer Sheet Construction and Assembly

As previously discussed in the context of FIG. 63A, implant 6300includes outer sheet 6360, which extends circumferentially about aproximal portion of frame 6355. Outer sheet 6360 provides variousfunctions including, but not limited to, protecting tissue around thevalve annulus from frame 6355, facilitating alignment of implant 6300within the valve annulus, and anchoring implant 6300 at its implantationlocation (e.g., through tissue ingrowth into outer sheet 6360). Furtherdetails regarding construction and assembly of outer sheet 6360 are nowprovided with reference to FIGS. 67A-67D.

FIG. 67A is a side view of the distal face of implant 6300. As shown,implant 6300 includes occluder 6302 at distal end 6340 and coupled toframe 6355. Implant 6300 further includes outer sheet 6360, whichextends circumferentially about a proximal portion of frame 6355 and isalso coupled to and supported by frame 6355. Although the shape of outersheet 6360 may vary, in the implementation shown in FIG. 67A, distalradially inward edge 6365 of outer sheet 6360 is circular and whileproximal radially outward edge 6366 has a sinusoidal/repeating shape.

FIG. 67B is a proximal side view of a section of frame 6355 and outersheet 6360 of implant 6300 and further illustrates assembly of outersheet 6360 to frame 6355. The specific view shown in FIG. 67Billustrates coupling of outer sheet 6360 to each of a first outer petalportion 6702A and a second outer petal portion 6702B of frame 6355.

Outer sheet 6360 is shown as being coupled to frame 6355 using bothsuture loops and hemming. For example, first outer petal portion 6702Aincludes a frame section 6704A and a frame section 6704B, with framesection 6704B extending between a distal vertex 6706 of first outerpetal portion 6702A and a junction 6708 formed between first outer petalportion 6702A and second outer petal portion 6702B. Along frame section6704B, three suture loops 6709A-6709C are placed to couple outer sheet6360 to frame 6355. Additional sutures loops are distributed aboutjunction 6708 to further reinforce the coupling of junction 6708 toframe 6355. An additional suture 6709D is positioned proximal junction6708 for further reinforcing the coupling between outer sheet 6360 andframe 6355 around junction 6708.

Outer sheet 6360 is also coupled to frame 6355 by hems extending alongeach of the proximal and distal edges of frame 6355. For example, afirst hem 6710 extends along radially inward edge 6365, enveloping thedistal vertices of the outer petal portions (e.g., distal vertex 6706 offirst outer petal portion 6702A). A second hem 6712 extends alongproximal radially outward edge 6366, conforming to the variable shape ofproximal radially outward edge 6366.

As shown, second hem 6712 is discontinuous and made up of discrete hemsections corresponding to the proximal halves of each outer petalportion. For example, first outer petal portion 6702A includes a firstpetal segment 6714A and a second petal segment 6714B that extendproximally and meet at a proximal vertex 6716. Outer sheet 6360 includesa first hem segment 6718A and a second hem segment 6718B that correspondto and contain first petal segment 6714A and second petal segment 6714B,respectively, with first hem segment 6718A folded over second hemsegment 6718B.

Second hem 6712 is shown as being discontinuous between petal portions,e.g., at junction 6708. Despite this continuity, the suture used to formthe discrete sections of second hem 6712 may be continuous and may berouted across the junctions between petal portions. For example, FIG.67B shows a suture segment 6722 that crosses junction 6708 and iscontinuous between first hem segment 6718A and second hem segment 6718B.

FIGS. 67C and 67D illustrate proximal vertex 6716 and distal vertex6706, respectively, in further detail. As shown in each figure, a suturewrap may be formed at one or both of proximal vertex 6716 and distalvertex 6706. For example, a proximal suture wrap 6724 is shown in FIG.67C extending around proximal vertex 6716 while a distal suture wrap6726 is shown in each of FIGS. 67C and 67D extending around distalvertex 6706. Including suture wraps as shown provides several notableadvantages. As a first example, each of the suture wraps provides robustand reinforced coupling of outer sheet 6360 to frame 6355. The suturewraps also provide additional padding around the vertices of the outerpetal portions of frame 6355. Finally, the suture wraps may fill gapsbetween hem segments. For example, proximal suture wrap 6724 is disposedbetween first hem segment 6718A and second hem segment 6718B and mayfill/cover any gap that may be present between the two segments despitethe folding of first hem segment 6718A over second hem segment 6718B.

FIG. 68 shows an example of outer sheet 6360 prior to coupling ontoframe 6355. As shown, outer sheet 6360 is a single piece of woven PETmaterial that is cut (e.g., laser cut) to conform to frame 6355 and toinclude various tabs, etc., to form any hems required to couple outersheet 6360 to frame 6355. FIG. 68 further indicates a first fold line6728 corresponding to first hem 6710 and a series of second fold lines6730 corresponding to second hem 6712.

In one example assembly process and following cutting of outer sheet6360, outer sheet 6360 is wrapped around frame 6355 as shown in thepreceding figures and sutured/stitched onto frame 6355. Suchsuturing/stitching generally includes forming each of first hem 6710 andsecond hem 6712 and forming any additional suture loops (e.g., sutureloops 6709A-6709). To facilitate wrapping oof outer sheet 6360 aboutframe 6355, outer sheet 6360 includes an open side 6732 that is closedas outer sheet 6360 is wrapped about frame 6355. To facilitate thisprocess, outer sheet 6360 may include an additional tab, such as tab6734, to keep outer sheet 6360 in a closed configuration while beingcoupled to frame 6355. Following initial wrapping of outer sheet 6360about frame 6355, tab 6734 may be folded inward (e.g., along fold line6736) and held in place by a suture/stitch. Doing so maintains anapproximate shape of outer sheet 6360 and facilitates folding andforming of the various hems and suture loops necessary to securelycouple outer sheet 6360 to frame 6355.

The foregoing discussion provides one example of construction andassembly of outer sheet 6360. In particular, the example includedcutting outer sheet 6360 from a sheet of suitable material (e.g., wovenPET) and attaching outer sheet 6360 to frame 6355 using a combination ofhems and suture loops. In suture-reliant implementations, coupling ofouter sheet 6360 to frame 6355 may be achieved using a monofilamentsuture, a multifilament suture, or a combination of mono- andmultifilament sutures. Also, this disclosure contemplates that outersheet 6360 may be coupled to frame 6355 using sutures, adhesives,welding, or any combination thereof. For example, in certainimplementations, one of heat welding or ultrasonic welding may be usedto close the various hems illustrated in the preceding figures. Asanother example, polyurethane, silicone, or a similarly suitable andbiocompatible adhesive, epoxy, bonding agent, etc., may be employed.This disclosure also contemplates that multiple fixation techniques maybe used to couple outer sheet 6360 to frame 6355. For example, adhesivemay be initially used to perform an initial or partial coupling of outersheet 6360 to outer sheet 6360 but may be supplemented or reinforced bysuturing, welding, etc.

XX. Implants Including Eyelets for Cinch Line Routing

Implant delivery systems of the present disclosure generally rely on twomechanisms for controlling expansion and collapse of implants duringdelivery. First, during delivery, implants according to this disclosuremay be disposed on a control arm assembly of the delivery tool. Thecontrol arm assembly includes control arms configured to radially expandand contract in response to manipulation of a corresponding control of ahandle assembly of the delivery tool. The control arm are coupled to theframe of the implant such that as a clinician expands the control armsradially outward, the implant expands. Similarly, as the clinicianretracts the control arms radially inward, the implant is pulled inwardand collapsed.

In addition to the control arms, delivery systems according to thepresent disclosure may include one or more cinch lines. The one or morecinch lines are routed through the delivery tool and made to extendcircumferentially about the frame of the implant. In implementationsincluding a single cinch line, the cinch line may be routed from ahandle assembly, through the catheter assembly of the delivery system(e.g., through a cinch line tube extending through the catheterassembly), about the full circumference of the implant, and back throughthe catheter assembly to the handle assembly.

In contrast, in implementations including multiple cinch lines, eachcinch line may be similarly routed through delivery catheter assembly,but only partially about the circumference of the implant. For example,in an implementation including two cinch lines, each cinch line mayextend about approximately half of the circumference of the implant andmeet at a retention location. Each cinch line may terminate in a loop orsimilar feature through which a retention pin or cable may be passed toretain the cinch lines during delivery and implantation.

During delivery and implantation, the one or more cinch lines providevarious functions and benefits. In general, the one or more cinch linesretain the implant on the control arms; however, by maintaining tensionof the one or more cinch lines during expansion and collapse of theimplant, the uniformity of expansion and collapse can be substantiallyimproved due to the cinch lines distributing expansion/collapse forcesevenly about the implant. Relatedly, maintain tension on the one or morecinch lines also provides improve responsiveness of the implantexpansion and collapse controls by reducing or eliminating slack thatmay need to be overcome before manipulation of a control by theclinician results in corresponding movement of the implant.

Regardless of whether one or more cinch lines are included, followingdelivery and implantation of the implant, the cinch lines must bedecoupled from the implant to permit release of the implant andsubsequent removal of the delivery system. In implementations includinga single cinch line that forms a large loop through the delivery system,the cinch line may be cut at a proximal location and subsequently pulledthrough the catheter assembly. In implementations including multiplecinch lines retained by a retention cable at the implant, the retentioncable may be retracted to release the cinch lines, which may then beretracted through the delivery catheter. This process and an examplehandle assembly for sequencing of retention cable and cinch lineretraction is described below in further detail in the context of FIGS.83A-86D.

Smooth and reliable retraction of the cinch lines is a critical part ofthe implantation process. For example, if the cinch lines bind, snag, orbecome otherwise restricted as they are retracted, the resulting pullingon the implant may result in the implant to shift within the valveannulus or, in certain extreme cases, to become partially or fullydislodged from its implantation location.

To avoid or reduce the likelihood of such situations, implementations ofthis disclosure include various features for more reliable andconsistent routing of cinch lines and, in particular, consistentretraction of cinch lines during release of the implant from thedelivery system. For example, in the implementation shown in FIG. 59 ,routing rings (e.g., ring 3646) are coupled to the control arms ofdelivery device 3600 and cinch line 3614 is routed through each of therouting rings and corresponding rings (e.g., ring 3804) coupled to theframe of implant 3800.

As another alternative, which is discussed in further detail in thissection, improved cinch line routing is provided by a series of eyeletscoupled to the implant frame. More specifically, specially designedeyelets are coupled to the frame of the implant such that the eyeletsare distributed circumferentially about the radially inward surface ofthe implant. In one specific implementation, the junctions betweenadjacent outer petal portions of the implant frame include a slotthrough which the separately manufactured eyelets are inserted. Incontrast to the rings included in the implementation shown in FIG. 59 ,the eyelets are rigidly retained using one or more coupling techniquesand form a consistent and reliable path for the one or more cinch linesabout the circumference of the implant. Additional features, such as asmooth, radius inner bore, reduce the likelihood of cinch lines bindingor snagging as they are retracted through the eyelets, thereby improvingthe overall reliability and consistency with which the cinch lines canbe retracted during release of the implant from the delivery device.

FIGS. 69A and 69B are a partial proximal view and a detailed proximalview, respectively, of implant 6300. Implant 6300 is discussed in detailin previous sections; however, implant 6300 generally includes frame6355, which includes a series of circumferentially distributed spokesthat extend from a distal frame portion 6358 to a proximal frame portion6359. Proximal frame portion 6359 includes a series of circumferentiallydistributed outer petal portions, such as outer petal portion 6385A andouter petal portion 6385B. Each pair of outer petal portions meet at ajunction, such as junction 6384. Each junction further connects with oneof the spokes extending from distal frame portion 6358. For example,junction 6384 connects outer petal portion 6385A, outer petal portion6385B, and spoke 6395A. In at least certain implementations, an anchormember, such as anchor member 6399 may also extend from junction 6384.

In certain implementations of this disclosure, each junction of frame6355 may further include an eyelet for use in routing one or more cinchline about the inner surface of implant 6300. For example, FIG. 69Billustrates an eyelet 6802 located at and coupled to junction 6384.Additional eyelets are also shown coupled to adjacent junctions. Incertain implementations, each junction of frame 6355 may include arespective eyelet such that the eyelets extend about the fullcircumference of implant 6300 and enable corresponding and completerouting of one or more cinch lines about implant 6300.

FIG. 70 is an isometric view of eyelet 6802, while FIGS. 71A-C are plan,bottom, and cross-sectional views of eyelet 6802, respectively. As shownin the figures, eyelet 6802 generally includes a shank 6804 extending ina first direction and a body 6808 extending perpendicularly from shank6804. In certain implementations, shank 6804 defines a retention hole6806 that may be used to couple eyelet 6802 to frame 6355 using a sutureloop or similar coupling element. Body 6808 similarly defines a cinchline hole 6810 that extends through body 6808 and that is generallysized and shaped to permit threading of the cinch line through cinchline hole 6810.

As shown in FIG. 70 , an undercut may be made on either side of body6808 where body 6808 meets shank 6804. For example, FIG. 70 indicatesundercut 6812A on a first side of body 6808 and undercut 6812B on anopposite side of body 6808. As discussed below in further detail,undercut 6812A and undercut 6812B facilitate flush contact between shank6804 and the proximal side of junction 6384 when eyelet 6802 isassembled with frame 6355.

FIGS. 71A-71C illustrate additional views of eyelet 6802 includingvarious dimensions. As in other aspects of this disclosure, the specificdimensions of eyelet 6802 may vary and any ranges or dimensionsspecifically mentioned in this disclosure in this and other sections areintended merely as examples that reflect certain positive outcomesduring development and testing.

Referring first to FIG. 71A, dimension W1 corresponds to a width of body6808, dimension D5 corresponds to a diameter of the through hole ofcinch line hole 6810, H11 corresponds to an offset between the topextent of shank 6804 and the beginning of the radius of cinch line hole6810, and D6 corresponds to a diameter of retention hole 6806. Incertain implementations, W1 may be from and including about 0.9 mm toand including about 1.0 mm and, in one specific example is approximately0.927 mm with a tolerance of +/-0.02 mm. In certain implementations, D5may be from and including about 0.55 mm to and including about 0.6 mmand, in one specific example is approximately 0.527 mm with a tolerance.In certain implementations, H11 may be from and including about 0.55 mmto and including about 0.65 mm and, in one specific example isapproximately 0.596 mm with a tolerance of +/-0.02 mm. In certainimplementations, D6 may be from and including about 0.35 mm to andincluding about 0.4 mm and, in one specific example is approximately0.38 mm.

FIG. 71B is a bottom view of eyelet 6802 and includes dimensions W2,which corresponds to the width of shank 6804, and T1, which correspondsto the thickness of eyelet 6802. In certain implementations, W2 may befrom and including about 1.8 mm to and including about 2.0 mm and, inone specific example is approximately 1.875 mm with a tolerance of+/-0.02 mm. In certain implementations, T1 may be from and includingabout 0.3 mm to and including about 0.4 mm and, in one specific exampleis approximately 0.36 mm with a tolerance of +/-0.02 mm.

Finally, FIG. 71C is a cross-sectional view of body 6808 across cinchline hole 6810 as indicated in FIG. 71A. As shown, in at least certainimplementations, cinch line hole 6810 may have radiused or otherwisemachined sides to eliminate any sharp edges that may catch or otherwiseimpede cinch line retraction. The radius of cinch line hole 6810 isindicated as R5 in FIG. 71C. In certain implementations, R5 may be fromand including about 0.15 mm to and including about 0.20 mm and, in onespecific example is approximately 0.18 mm.

FIG. 72 is a detailed view of junction 6384 with eyelet 6802 removed.More specifically, FIG. 72 is a detailed view from a perspectiveorthogonal to a slot 7202 on a distal side of frame 6355. As previouslydiscussed, junction 6384 provides a connection location between spoke6395A, outer petal portion 6385A, and outer petal portion 6385B, andanchor member 6399 may extend outward from junction 6384.

Slot 7202 is defined by and extends through junction 6384 and is shapedto receive eyelet 6802. For example, in certain implementations, slot7202 may be laser cut or otherwise formed in the same process as therest of frame 6355 (e.g., a process by which frame 6355 is laser cutfrom a tubular substrate, such as a nitinol tube). Slot 7202 may vary insize and shape depending on the scale of frame 6355 and, morespecifically, the size and shape of eyelet 6802. Nevertheless, incertain implementations, slot 7202 may generally have a width W2 and alength L1, with W2 corresponding to a dimension extending perpendicularto spoke 6395A and L extending parallel to spoke 6395A. Althoughdimensions of W and L may vary, in certain implementations, W may befrom and including about 0.3 mm to and including about 0.5 mm. Forexample, W2 may be approximately 0.405 mm with a tolerance of +/- 0.03mm. Similarly, L1 may vary in different implementations of thisdisclosure; however, in certain implementations, L1 may be from andincluding about 0.75 mm to and including about 1.5 mm. In one specificexample, L1 is approximately 1.075 mm with a tolerance of +/- 0.03 mm.

FIG. 73A is a cross-sectional view of junction 6384 with eyelet 6802installed. As shown, eyelet 6802 is inserted through slot 7202 such thatshank 6804 of eyelet 6802 abuts a distal surface 7302 of junction 6384and cinch line hole 6810 extends to a proximal side 7304 of junction6384, with the contact between shank 6804 and distal surface 7302precluding further proximal movement by eyelet 6802. Eyelet 6802 isshown as being coupled to junction 6384 by a suture loop 7306 thatextends about junction 6384 and is threaded through retention hole 6806of eyelet 6802. In other implementations, eyelet 6802 may be retainedwithin slot 7202 using alternative or additional means. For example,eyelet 6802 may be bonded to junction 6384 using an adhesive or by awelding process. As another alternative slot 7202 and body 6808 ofeyelet 6802 may be sized such that an interference fit is formed betweenslot 7202 and body 6808 that positively retains eyelet 6802 within slot7202. As further illustrated in FIG. 73A, outer sheet 6360 is generallydisposed distal shank 6804 when implant 6300 is fully assembled.Accordingly, outer sheet 6360 may also be fitted to abut and applyproximal force to shank 6804 to facilitate retention of eyelet 6802within slot 7202.

FIG. 73B is similarly a cross-sectional view of junction 6384 witheyelet 6802 installed albeit with implant 6300 coupled to a control arm7308 of a delivery tool and with a cinch line 7310 routed through cinchline hole 6810 of eyelet 6802. As shown, control arm 7308 includes ahole or slot 7312 shaped to receive body 6808 of eyelet 6802. Followinginsertion of eyelet body 6808 through slot 7312, cinch line 7310 can berouted through cinch line hole 6810, thereby retaining implant 6300 ontocontrol arm 7308. This general assembly process is then repeated foreach eyelet of implant 6300 and each corresponding control arm of thedelivery device.

Following placement of implant 6300, cinch line 7310 is released (e.g.,by cutting and pulling or retraction of a retention pin/cable) andretracted. During retraction, cinch line 7310 passes through cinch linehole 6810. Once cinch line 7310 is clear of cinch line hole 6810,control arm 7308 is separable from eyelet 6802, thereby enabling releaseof implant 6300 from the delivery tool.

This disclosure contemplates that eyelet 6802 may be formed andmanufactured using various materials and processed. Nevertheless, in onespecific implementation, eyelet 6802 is formed from titanium that isprecision machined, cleaned, and electropolished prior to assembly withframe 6355.

XXI. Delivery Tools Including Internal Tubes with Modified Flexibility

FIGS. 36-44 illustrated various features and components of deliverydevice 3600, which is a non-limiting example of an implant deliverydevice according to this disclosure. As described in the context ofFIGS. 36-44 , delivery device 3600 includes delivery catheter 3604,which is the primary steerable element of delivery device 3600. Deliverydevice 3600 further includes various tubes and shafts within deliverycatheter 3604 for performing various functions of delivery device 3600.For example, tube 3626 provides a conduit through which control armshaft 3642 and control arm assembly 3608 extend.

In addition to providing protection and support for control arm shaft3642 and control arm assembly 3608, in at least some implementations,tube 3626 is also extendible and retractable relative to deliverycatheter 3604 to facilitate positioning of the implant during theimplantation process. An implementation of this disclosure capable ofsuch extension and retraction and corresponding control mechanisms isillustrated in FIGS. 79A-79D and discussed further below.

In general, extension and retraction of distal tube 3626 requires thatdistal tube 3626 have sufficient axial strength and rigidity to transferlongitudinal forces imparted at a handle assembly of the delivery systemefficiently and responsively. However, given that delivery catheter 3604is steerable, distal tube 3626 must also be sufficiently flexible topermit steering of delivery catheter 3604 without imparting substantialresistance.

To address these challenges, among others, this disclosure provides foran internal tube for an implant delivery system that is both stiffenough to transfer forces necessary for extension and retraction of animplant supported on the distal end of the tube and flexible enough soas not to substantially impact steering and control of the deliverycatheter within which the tube is contained. As described below infurther detail, these goals are achieved by forming a substantial lengthof the tube with a uniform and relatively stiff construction. Certaindistal sections of the tube that generally correspond to the steerablesections of the delivery catheter further include slits, cutouts,helical cuts, or similar features that locally reduce bending stiffnessof the tube without substantially altering axial strength and forcetransfer characteristics. In some implementations, such stiffnessreduction features may be configured to reduce stiffness of the tube tobending along a specific plane or in a specific direction, e.g., along aplane corresponding to a steering plane of the delivery catheter, whilemaintaining rigidity with respect to bending in other directions.

FIG. 74 illustrates an example delivery system 7400 for an implant 7402.Delivery system 7400 generally corresponds to delivery device 3600,discussed above. As noted in the context of delivery device 3600,delivery system 7400 includes a steerable catheter 7404 includingmultiple steerable sections. While other configurations and steeringarrangements of steerable catheter 7404 are contemplated by and withinthe scope of this disclosure, steerable catheter 7404 generally includesa distal steerable section 7406 steerable along a first plane (e.g.,plane 4506, shown in FIG. 45A with bending along plane 4506 furtherillustrated in FIGS. 45B and 45C) and a proximal steerable section 7408steerable along two planes (e.g., plane 4508 and plane 4510 shown inFIG. 45A with steering along the planes shown in FIGS. 45D and 45E andFIGS. 45F-45H, respectively). In certain implementations, the firststeering plane of proximal steerable section 7408 may be coplanar withthe steering plane of distal steerable section 7406 when steerablecatheter 7404 is in a neutral/straight configuration while the secondsteering plane of proximal steerable section 7408 may be orthogonal tothe first steering plane of proximal steerable section 7408. Steerablecatheter 7404 may also include one or more non-steerable cathetersections, such as non-steerable catheter section 7409. For example,non-steerable catheter section 7409 may extend from proximal steerablesection 7408 to a handle assembly of delivery system 7400.

Delivery system 7400 includes an internal tube 7410. The specificfunctions of internal tube 7410 may vary; however, in at least certainimplementations internal tube 7410 enables routing of elongate elementsthrough steerable catheter 7404. In delivery system 7400, internal tube7410 is also translatable relative to steerable catheter 7404 tofacilitate positioning and placement of implant 7402 during delivery andimplantation. An example of such extension and retraction is providedbelow in the context of FIGS. 79A-80B, which illustrate and describeextension and retraction of an inner tube and a corresponding handlemechanism for performing extension/retraction.

While this disclosure contemplates that internal tube 7410 may have asubstantially uniform structure, in at least certain implementationsinternal tube 7410 is divided into sections with varying stiffnesses andproperties related to bending of the particular section. Certainsections may also have non-uniform stiffness, such as by having a firststiffness when bent along a first plane and/or in a first direction anda second, different stiffness when bent along a second plane and/or in asecond direction.

FIG. 75 illustrates internal tube 7410 removed from delivery system7400. As shown, internal tube 7410 is generally divided into foursections, each of which has a different structure. While implementationsof this disclosure may vary, internal tube 7410 specifically includes adistal tube section 7412, a first medial section 7414, a second medialtube section 7416, and a proximal tube section 7418. Each section ofinternal tube 7410 may correspond to a particular section of steerablecatheter 7404. For example, in the implementation shown, distal tubesection 7412 may correspond to distal steerable section 7406, firstmedial section 7414 may correspond to proximal steerable section 7408,second medial tube section 7416 may correspond to a distal segment ofnon-steerable catheter section 7409, and proximal tube section 7418 maycorrespond to a proximal segment of non-steerable catheter section 7409.

Although the specific construction of internal tube 7410 may vary, in atleast certain implementations, internal tube 7410 is formed as a unitarytubular structure. Material of internal tube 7410 may similarly vary;however, in one specific implementation, internal tube 7410 is formedfrom stainless steel or a similar biocompatible material. In at leastone implementation, internal tube 7410 is formed from a tube having anouter diameter from and including about 2.5 mm to and including about3.5 mm with a wall thickness from and including about 0.1 mm to andincluding about 0.5 mm. For example, in one specific implementation,internal tube 7410 has an outer diameter of approximately 3 mm and awall thickness of 0.25 mm.

FIGS. 76A-76D illustrate each section of internal tube 7410 in furtherdetail. FIG. 76A is a side view of distal tube section 7412 of internaltube 7410. When assembled with steerable catheter 7404, distal tubesection 7412 generally corresponds to distal steerable section 7406.

As noted above, in the specific implementation illustrated in FIG. 74 ,distal steerable section 7406 of steerable catheter 7404 isbidirectionally steerable along a single plane. To accommodate suchbending of distal steerable section 7406, distal tube section 7412 maybe configured to have reduced stiffness to bending along the steeringplane of distal steerable section 7406.

In one specific implementation, stiffness of distal tube section 7412 ismodified by a series of cuts distributed longitudinally along distaltube section 7412. More specifically, distal tube section 7412 includesfirst cuts 7420A extending along a first side of distal tube section7412 and second cuts 7420B extending along a second side of distal tubesection 7412. First cuts 7420A and second cuts 7420B reduce thestiffness of distal tube section 7412 relative to bending in thedirections of the sides along which the cuts extend. In contrast,relatively higher stiffness is maintained for bending in directionsorthogonal to the cut sides due to “spines” (e.g., spine 7421) thatextend along distal tube section 7412 between the sets of cuts. Wheninternal tube 7410 is disposed within steerable catheter 7404, firstcuts 7420A and second cuts 7420B are generally oriented perpendicular tothe steering plane of distal steerable section 7406 such that resistanceto bending by distal tube section 7412 along the steering plane isreduced.

As illustrated in FIG. 76A, each of first cuts 7420A and second cuts7420B terminate in a bulbous cutout, resulting in an overall dog-boneshape to each of the cuts. The dog-bone shape generally reducesinterference of the internal cut surfaces during bending. Among otherthings, doing so promotes more uniform bending of distal tube section7412 and avoids binding of distal tube section 7412 during bending.

To maintain proper orientation between internal tube 7410 and steerablecatheter 7404 a keyway 7422 or similar alignment feature of distal tubesection 7412 may mate with a corresponding feature of steerable catheter7404.

While FIG. 76A illustrates lateral cuts for reducing bending stiffnessalong one plane, this disclosure contemplates that lateral cuts may alsobe used to reduce stiffness of a given section of internal tube 7410 tobending along multiple planes. For example, internal tube 7410 may bemodified by including additional cuts orthogonally offset from firstcuts 7420A and second cuts 7420B and disposed between adjacent cuts offirst cuts 7420A and second cuts 7420B. By doing so, stiffness ofinternal tube 7410 may also be reduced to bending along a second planorthogonal to the first plane corresponding to first cuts 7420A andsecond cuts 7420B. More generally, by angularly offsetting the lateralcuts along internal tube 7410, internal tube 7410 can be made to havereduced stiffness along any number and direction of bending planes.Stiffness along a given bending plane may be controlled by modifying thedensity, kerf, depth, or other similar characteristics of the cutscorresponding to the bending plane. Accordingly, in implementations inwhich internal tube 7410 has controlled stiffness in multiple directionsor along multiple planes, the cut characteristics for each plane may bemodified and controlled to impart specific bending characteristics forthe direction/plane.

FIG. 76B is a side view of first medial section 7414 of internal tube7410. As noted above, in the specific implementation illustrated in FIG.74 , proximal steerable section 7408 of steerable catheter 7404 issteerable along two orthogonal planes. To accommodate such bending,first medial section 7414 may be configured to have omnidirectionallyreduced stiffness to bending.

In one specific implementation, stiffness of first medial section 7414is modified by one or more helical cuts, such as helical cut 7424,extending along the length of first medial section 7414. Given thathelical cut 7424 extends around the entirety of first medial section7414, it reduces stiffness of first medial section 7414omnidirectionally relative to stiffness of first medial section 7414absent any such cuts.

FIG. 76C is a side view of second medial tube section 7416 of internaltube 7410. As noted above, in the specific implementation illustrated inFIG. 74 , second medial tube section 7416 may correspond to a distalsegment of non-steerable catheter section 7409 of steerable catheter7404.

While not requiring the flexibility to accommodate steering, reducedstiffness of second medial tube section 7416 may nevertheless bedesirable in certain applications and procedures. For example, duringdelivery of an implant to the valve annulus using delivery system 7400,the distal segment of non-steerable catheter section 7409 correspondingto second medial tube section 7416 is near and may even extend into theheart. As such, the distal segment of non-steerable catheter section7409 may contact and exert forces on tissue and structures of andsurrounding the heart, particularly during changes in insertion and/orrotation of steerable catheter 7404. In general, internal tube 7410structurally reinforces steerable catheter 7404 and contributes to thecontact forces between steerable catheter 7404 and surrounding tissue.So, by reducing the stiffness of second medial tube section 7416, thedegree of structural reinforcement provided to the distal segment ofnon-steerable catheter section 7409 and corresponding contact forcesexerted by non-steerable catheter section 7409 can be reduced.

In one specific implementation, stiffness of second medial tube section7416 is modified by one or more helical cuts, such as helical cut 7426,extending along the length of second medial tube section 7416. Giventhat helical cut 7426 extends around the entirety of second medial tubesection 7416, it reduces stiffness of second medial tube section 7416omnidirectionally. Compared to helical cut 7424 of first medial section7414, helical cut 7426 of second medial tube section 7416 is illustratedas having a greater pitch, resulting in a smaller reduction in thestiffness of second medial tube section 7416.

FIG. 76D is a side view of proximal tube section 7418 of internal tube7410. As shown, proximal tube section 7418 does not include any specificmodifications to change the general stiffness of proximal tube section7418. However, as shown, proximal tube section 7418 may include acoupling feature 7428, such as an elongate through hole, for coupling toa handle of delivery system 7400 and maintaining rotational alignment ofinternal tube 7410 with respect to steerable catheter 7404 whilepermitting longitudinal translation of internal tube 7410 relative tosteerable catheter 7404.

This disclosure contemplates various aspects of the cuts illustrated inFIGS. 76A-76C may be modified to impart different stiffness reductionsto internal tube 7410 and to tune the stiffness of internal tube 7410for a given application. For example, with reference to the lateral cutsshown in FIG. 76A, cut density (i.e., cuts per unit length of internaltube 7410), kerf width, cut depth, and similar characteristics may bemodified to modify the stiffness. Similarly, with respect to the helicalcuts shown in FIGS. 76B and 76C, pitch, kerf, helix angle, and similarcharacteristics may be modified to alter the stiffness of internal tube7410.

While FIGS. 76A-76C illustrate cuts through a wall of internal tube7410, this disclosure also contemplates that any cuts may extend onlypartially through the wall of internal tube 7410, with the depth of thecut being generally proportional to the stiffness reduction provided bythe cut. This disclosure also contemplates that the stiffness ofsections of internal tube 7410 may be modified in other ways including,but not limited to, varying wall thickness, varying tube material,varying tube shape, and the like.

The specific dimensions of internal tube 7410 may vary. However, incertain implementations, internal tube 7410 may be from and includingabout 1400 mm to and including about 1800 mm. For example, in oneimplementation, internal tube 7410 may be approximately 1540 mm inlength. Each section of internal tube 7410 may similarly vary in length.For example, in one implementation, distal tube section 7412 may be fromand including about terminate in a distal end including a keyway orsimilar non-rotational feature that is from and including about 40 mm toand including about 80 mm in length. For example, distal tube section7412 may be approximately 60 mm in length. In certain implementations,first medial section 7414 may be from and including about 90 mm to andincluding about 130 mm. For example, first medial section 7414 may beapproximately 110 mm in length. In certain implementations, the spiralcut of first medial section 7414 may have a pitch from and includingabout 0.4 mm to and including about 0.6 mm, e.g, 0.5 mm. In someimplementations, the spiral cut of first medial section 7414 iscontinuous; however, in others, it may be an interrupted cut with cutlengths of approximately 2 mm to 4 mm interspersed with uncut sectionsof approximately 0.5 mm to approximately 0.8 mm. More generally,however, each of distal tube section 7412 and first medial section 7414may be approximately the same length as the corresponding steerablesections of the delivery catheter with which they are paired and withinwhich they are disposed. Second medial tube section 7416 may similarlyvary in length. For example, in certain implementations, second medialtube section 7416 may be from and including about 500 mm to andincluding about 700 mm in length. In one specific example, second medialtube section 7416 is approximately 630 mm in length. In certainimplementations in which second medial tube section 7416 is spiral cut,the spiral cut of second medial tube section 7416 may have a pitch fromand including about 1 mm to and including about 2 mm, e.g., 1.5 mm. Thespiral cut of second medial tube section 7416 may similarly beuninterrupted or interrupted. When the spiral cut is interrupted, it mayinclude cut segments from and including about 3 mm to and includingabout 4 mm, e.g., 3.5 mm, and uncut segments of 0.5 mm to 1.2 mm, e.g.,0.9 mm. Finally, in certain implementations, proximal tube section 7418may be from and including about 600 mm to and including about 800 mmand, in one specific example, is approximately 740 mm.

XXII. Delivery Tool Handles for Delivery of Expandable Implants

Delivery tools according to this disclosure generally include a handleassembly with various control elements and a catheter assembly extendingform the handle assembly. During delivery of an implant, the implant isretained within at least partially within a distal end of the catheterassembly. Following insertion of the catheter assembly and location ofthe distal end of the catheter assembly by a clinician, the cliniciandeploys the implant from the distal end of the catheter assembly.Deployment generally includes fully exposing the implant, such as byretracting a protective sheath and/or distally extending the implantfrom the distal end of the catheter assembly, and once exposed,expanding the implant into an expanded configuration for implantation.Following final positioning and implantation of the now-expandedimplant, the clinician detaches the implant from the distal end of thecatheter assembly and retracts the delivery tool from the patient.

The foregoing process requires substantial control and manipulation ofthe delivery tool and the implant including, but not limited to,steering of the catheter assembly, extension and retraction of theimplant relative to the catheter assembly, expansion and contraction ofthe implant, and release of the implant. An example steering mechanismand corresponding handle features and functions are discussed above inthe context of FIGS. 45-49 . As noted in the context of those figures,the handle assembly may include levers or similar steering controlelements configured to steer sections of the catheter assemblyindependently and in multiple directions. For example, FIG. 45illustrates one example implementation in which a distal portion of thecatheter assembly is separated into a proximal steering section and adistal steering section, each of which is independently articulable.

In addition to steering of the catheter, certain implementations of thisdisclosure include elements for controlling each of rotation andinsertion of the catheter assembly. For example, FIG. 61 illustrates anexample delivery device mount that includes a rail and cradle supportingthe delivery device. The cradle is movable/translatable along the rail(e.g., by turning a corresponding knob) to control insertion. The cradlealso includes a rotatable mount for the delivery device such that thedelivery device may be rotated within the cradle while maintaininglongitudinal alignment.

FIGS. 77A-78C illustrate a similar mounting arrangement for enablingboth insertion and rotation of a delivery device. FIG. 77A is aphotograph of an implant delivery system 7700 including a deliverydevice 7702 supported by a mounting assembly 7704 including a cradle7706. Cradle 7706 is supported by a rail 7708 supported by anarticulating arm 7710. While not shown in the figures, articulating arm7710 may be coupled to a patient bed or similar fixture within anoperating environment. Similar to the mounting arrangement shown in FIG.61 , cradle 7706 includes a stepper-type articulation system that ismanually driven by a knob 7712. More specifically, as a clinicianrotates knob 7712 (as shown in FIG. 77B), cradle 7706 translates alongrail 7708 in a corresponding direction, thereby controlling insertion ofdelivery device 7702.

FIGS. 78A-78C illustrate rotation of delivery device 7702 within cradle7706 of mounting assembly 7704. FIG. 78A illustrates delivery device7702 in a neutral position. To modify rotational position of deliverydevice 7702, a clinician may manually rotate delivery device 7702 withincradle 7706. FIG. 78B illustrates delivery system 7700 during manualrotation of by a clinician in a first direction from the neutralposition of FIG. 78A while FIG. 78C illustrates delivery device 7702following rotation by a clinician in an opposite direction from neutral.Notably, during rotation in either direction, the longitudinal axis ofdelivery device 7702 is maintained in a fixed location. While the amountof rotation provided by mounting assembly 7704 may vary, in at leastcertain implementations, mounting assembly 7704 may be configured toprovide up to and including about 180 degrees of total rotation fordelivery device 7702, e.g., 90 degrees in either a clockwise orcounterclockwise direction relative to neutral.

In addition to rotation and insertion, delivery systems according to thepresent disclosure can be actuated and controlled in other ways withcorresponding control elements included in their handle assemblies. Byway of non-limiting example, such additional degrees of freedom andarticulation may include extension of an implant relative to a distalend of a delivery catheter, controlled expansion and contraction of theimplant prior to release, and controlled release of the implant from thedistal end of the delivery catheter, each of which is discussed below infurther detail.

First, FIGS. 79A-80B illustrate an example implementation of a deliverydevice 7900 having a handle assembly 7902. Like other delivery devicesand systems of this disclosure, delivery device 7900 generally includesa steerable catheter assembly 7904. An implant 7950 may be disposed on adistal end 7906 of the catheter assembly 7904 for delivery andimplantation. The catheter assembly 7904 includes a steerable catheterbody 7908 and an extension tube 7910. During operation and as discussedin the context of FIGS. 54A and 54B and FIG. 74-76E, extension tube 7910may be extended and retracted relative to distal end 7906 to facilitatepositioning, orientation, and placement of implant 7950 relative to thevalve annulus.

In one example tricuspid valve repair procedure, implant 7950 ismaintained in a retracted and sheathed configuration during delivery ofdistal end 7906 of delivery device 7900 into the right atrium and withimplant 7950 coupled to distal end 7906. With distal end 7906 in theright atrium, the clinician unsheathes and expands implant 7950 andaligns implant 7950 to be normal to the tricuspid valve annulus, e.g.,by steering catheter assembly 7904. Once aligned, extension tube 7910 isextended to translate implant 7950 into the valve annulus for subsequentrelease.

FIGS. 79A-79D illustrate general operation of handle assembly 7902 ofdelivery device 7900 to perform extension and retraction of implant7950. More specifically, FIGS. 79A and 79C are photographs of handleassembly 7902 with extension tube 7910 and implant 7950 in a fullyextended configuration and during retraction, respectively. Similarly,FIGS. 79B and 79D are photographs of distal end 7906 of delivery device7900 with extension tube 7910 and implant 7950 in a fully extendedconfiguration and during retraction, respectively.

Extension and retraction of extension tube 7910 and implant 7950 isachieved by an extension control element 7912 of handle assembly 7902.In the specific implementation shown, extension control element 7912 isin the form of an extension knob 7914 that is rotatable by a clinicianto selectively extend and retract extension tube 7910. Morespecifically, rotation of extension control element 7912 in a firstdirection (e.g., clockwise) results in extension of extension tube 7910while rotation in a second, opposite direction (e.g., counterclockwise)results in retraction of extension tube 7910.

FIGS. 79A and 79C generally illustrate handle assembly 7902 having ahousing 7916. Housing 7916 includes an aperture 7918 to visuallycommunicate the state of delivery device 7900 and, in particular,extension of extension tube 7910 and implant 7950. This disclosurecontemplates that various techniques may be used to visually indicateextension of extension tube 7910 and implant 7950; however, as shown inFIGS. 79A and 79C, extension/retraction of extension tube 7910 isgenerally communicated by the relative position of a shuttle indicator7922 disposed on an extension shuttle 7924. Extension tube 7910 iscoupled to and extends distally from extension shuttle 7924 such thattranslation of extension shuttle 7924 corresponds to translation ofextension tube 7910. So, as the clinician extends and retracts extensiontube 7910 and implant 7950, extension shuttle 7924 translates withinaperture 7918, moving the location of shuttle indicator 7922 andcommunicating translation of extension tube 7910. A scale 7926 iscoupled to housing 7916 adjacent shuttle indicator 7922 and includesmarkers corresponding to various degrees of extension and retraction ofextension tube 7910 to communicate the current extension/retractionstate to the clinician.

FIGS. 80A and 80B illustrate delivery device handle assembly 7902 withhousing 7916 removed and are intended to explain operation of handleassembly 7902 to extend and retract extension tube 7910. Morespecifically, FIG. 80A illustrates handle assembly 7902 in a first statecorresponding to extension tube 7910 being in a fully extendedconfiguration (e.g., similar to that illustrated in FIGS. 79A and 79B)while FIG. 80B illustrates handle assembly 7902 in a second statecorresponding to extension tube 7910 being in a fully retractedconfiguration (e.g., similar to that illustrated in FIGS. 79C and 79D).Shuttle indicator 7922 is also included in FIGS. 80A and 80B in positionbut decoupled from housing 7916 for purposes of more clearlyillustrating shuttle indicator 7922 and its relationship with extensionshuttle 7924.

Handle assembly 7902 is operable to selectively extend and retractextension tube 7910 between the fully extended configuration shown inFIG. 80A and the fully retracted configuration shown in FIG. 80B byrotation of extension knob 7914. Extension knob 7914 can be rotated ineither direction to selectively extend and retract extension tube 7910and can be used to translate extension tube 7910 into a fully extendedconfiguration, a fully retracted configuration, or any intermediate(e.g., partially extended/retracted) configuration.

Extension knob 7914 is coupled to an extension shaft 7928 that extendsdistally from extension knob 7914 into housing 7916 and is coupled to adistal member 7930 of housing 7916, thereby longitudinally fixingextension shaft 7928. Extension shaft 7928 is at least partiallythreaded and extends through a threaded hole 7932 of extension shuttle7924. As shown, extension shuttle 7924 further may include one or moreguide bores (e.g., guide bore 7925) through which corresponding guidemembers (e.g., guide member 7927) extend to maintain alignment of and tosupport extension shuttle 7924 and along which extension shuttle 7924translates. As extension knob 7914 is rotated, extension shaft 7928longitudinally drives extension shuttle 7924 along the guide membersand, as a result, extends or retracts extension tube 7910 based on thedirection of rotation of extension knob 7914.

FIGS. 81A-81D illustrate operation of a second control mechanism ofhandle assembly 7902 and, specifically, a control mechanism configuredto selectively expand and collapse implant 7950. FIGS. 81A and 81Billustrate delivery device 7900 in a first configuration in whichimplant 7950 is in a collapsed state. As shown in FIG. 81A, handleassembly 7902 includes an expansion control element 7934 in the form ofan expansion knob 7936. During operation and following unsheathing andextension of implant 7950 from the distal end of catheter assembly 7904,expansion knob 7936 is rotatable to selectively expand and collapseimplant 7950. FIGS. 81C and 81D, for example, illustrate delivery device7900 in a second configuration in which implant 7950 has been fullyexpanded by rotation of expansion knob 7936 in a first direction. In theillustrated implementation, expansion knob 7936 is bidirectionallyrotatable such that implant 7950 can be selectively expanded andcollapsed between the fully expanded state in FIG. 80D, the fullycollapsed state in FIG. 80B, or any intermediate state ofexpansion/collapse.

While the specific mechanical configuration of delivery devices andimplants according to this disclosure may vary, expansion and collapseof the implant by the delivery device during delivery generally requirestwo actions. Expansion is generally achieved by applying radiallyoutward and circumferentially distributed force to the implant. Forexample, as previously discussed in the context of delivery device 3600in FIGS. 38-44 , delivery device 3600 includes circumferentiallydistributed control arms (such as the control arms of control armassembly 3608 shown in FIGS. 42 and 43 ) that can be made to extendradially and apply radially outward force by longitudinal translation ofcontrol arm shaft 3642.

To facilitate uniform and controlled expansion of the implant, deliverydevices according to this disclosure also include one or more cinchlines configured to be run circumferentially about the implant duringdeployment. For example, delivery device 3600 is a single cinch lineimplementation with cinch line 3614 indicated in FIG. 38 . As discussedbelow in the context of release mechanisms for delivery device 7900, thespecific implementation of delivery device 7900 generally includes two,simultaneously controllable cinch lines. In other implementations,delivery devices of this disclosure may include one or more than twocinch lines as described below in further detail in the context ofimplant release controls. During expansion of the implant and asradially outward force is applied by the control arms, the one or morecinch lines of the delivery device are paid out while maintaining thecinch lines under tension. Among other things, maintaining tension onthe cinch lines distributes the radial forces applied by the controlarms around the circumference of the implant and improves generalresponsiveness of expansion/collapse of the implant to manipulation of acorresponding control element (e.g., expansion knob 7936 of handleassembly 7902).

Collapsing the implant similarly involves coordinated movement of thecontrol arms and while maintaining tension on one or more cinch lines.In contrast to expansion of the implant during which the control armsare made to extend radially outward by distal translation of the controlarm shaft, collapse is achieved by radially collapsing the control armsby proximally translating the control arm shaft. During collapse,tension is maintained on the one or more cinch lines extending about theimplant to facilitate uniform collapse of the implant with goodresponsiveness to manipulation of the corresponding control element(e.g., expansion knob 7936 of handle assembly 7902).

In summary, expansion of the implant involves radial extension of thecontrol arms by distal translation of the control arm shaft and acorresponding payout of the one or more cinch lines under tension as theimplant expands. Similarly, collapse of the implant involves radiallyretraction of the control arms by proximal translation of the controlarm shaft and a corresponding retraction of the one or more cinch linesthat maintains tension on the one or more cinch lines as the implantcollapses.

In certain implementations, translation of the control arm shaft andcinch line tension may be independently controllable by a clinicianusing corresponding control elements of the delivery device handle. Inother implementations, such as delivery device 7900, control arm shafttranslation and cinch line control are synchronized to operation of asingle control element, i.e., expansion knob 7936. Stated differently,rotation of expansion knob 7936 in a first direction results in bothdistal translation of a control arm shaft (and, as a result, radialexpansion of the control arms) and a synchronized and proportionalpaying out of the one or more cinch lines to maintain tension on the oneor more cinch lines. Rotation of expansion knob 7936 in a seconddirection results in both proximal translation of the control arm shaft(and, as a result, radial retraction of the control arms) and asynchronized and proportional retraction of the one or more cinch linesto maintain tension on the one or more cinch lines.

An example mechanism for achieving synchronized control arm shaft andcinch line manipulation is illustrated in FIGS. 82A-82C, whichillustrate handle assembly 7902 with housing 7916 removed. Morespecifically, FIG. 82A illustrates handle assembly 7902 in a statecorresponding to full collapse of the implant 7950 (e.g., as shown inFIGS. 81A and 81B), FIG. 82B shows a partially transparent detailed viewof extension shuttle 7924, and FIG. 82C illustrates handle assembly 7902in a state corresponding to full expansion of implant 7950 (e.g., asshown in FIGS. 81C and 81D).

Referring first to FIG. 82A, expansion knob 7936 is coupled to anexpansion shaft 7938 that extends from expansion knob 7936 into housing7916. Expansion shaft 7938 terminates proximally at extension shuttle7924 and is coupled to extension shuttle 7924 such that expansion shaft7938 remains longitudinally fixed relative to extension shuttle 7924. Asdescribed below in further detail, rotation of expansion shaft 7938generally drives rotation of a spool 7944 supported on extension shuttle7924. Notably, while rotation of expansion knob 7936 causes rotation ofspool 7944, rotation of expansion knob 7936 does not cause translationof extension shuttle 7924 and corresponding extension/retraction ofextension tube 7910 and implant 7950. Stated differently, expansion andcollapse of the implant is controllable independent of longitudinaltranslation of implant 7950 by extension tube 7910.

Housing 7916 further contains an expansion shuttle 7940 coupled to acontrol arm shaft 7942. Expansion shuttle 7940 includes a threadedcoupling 7943 or similar threaded structure through which expansionshaft 7938 extends. Expansion shuttle 7940 may further include one ormore guide bores (e.g., guide bore 7946) through which correspondingguide members (e.g., guide member 7948) may extend to maintain alignmentof expansion shuttle 7940 and guide translation of expansion shuttle7940 within housing 7916. As expansion shaft 7938 is rotated, expansionshaft 7938 longitudinally drives expansion shuttle 7940 along the guidemembers and, as a result, extends or retracts control arm shaft 7942based on the direction of rotation of expansion knob 7936.

As previously noted, operation of expansion knob 7936 effects bothtranslation of control arm shaft 7942 and corresponding payout orretraction of the one or more cinch lines of delivery device 7900. FIG.82B illustrates extension shuttle 7924 in partial transparency forpurposes of illustrating cinch line control by rotation of expansionknob 7936. As shown, extension shuttle 7924 includes spool 7944, whichis supported on a body 7952 by a gear 7956 that is threadedly engaged toa worm gear 7958 coupled to expansion shaft 7938. As a clinician rotatesexpansion shaft 7938 using expansion knob 7936, worm gear 7958 drivesgear 7956, causing rotation of spool 7944. As illustrated, a tether 7960extends around spool 7944 and is coupled to each of a first cinch line7962 and a second cinch line 7964. As spool 7944 rotates in response torotation of expansion knob 7936, tether 7960 spools onto or is paid outfrom spool 7944, thereby retracting or paying out each of first cinchline 7962 and second cinch line 7964.

Referring back to FIG. 82A, spool 7944 may include a faceplate 7945 thatmay further include markings for indicating the relative rotation ofspool 7944. Given that spool 7944 rotates in response to expansion andcontraction of implant 7950, markings on faceplate 7945 or similarmarkings on spool 7944 or extension shuttle 7924 indicating the relativerotation of spool 7944 may be used to communicate the degree to whichimplant 7950 is expanded/collapsed.

As noted above, rotating expansion knob 7936 results in simultaneoustranslation of expansion shuttle 7940 (translating control arm shaft7942) and corresponding retraction/payout of the one or more cinch linesof handle assembly 7902. Synchronization between these two functions isprimarily dictated by the interaction between worm gear 7958 and gear7956, which collectively form a gearbox or similar transmission system.More specifically, the gear ratio between worm gear 7958 of control armshaft 7942 and gear 7956 coupled to spool 7944 dictates the relationshipbetween rotation of expansion shaft 7938 and the rotation of spool 7944.Given that expansion shaft 7938 is coupled to and directly drivesexpansion shuttle 7940 and that spool 7944 drives retraction and payoutof the one or more cinch lines, the gear ratio between worm gear 7958and gear 7956 also dictates the relationship between translation ofcontrol arm shaft 7942 and payout/retraction of the one or more cinchlines.

Synchronizing the one or more cinch lines with translation of thecontrol arms involves modifying the circumference formed by the one ormore cinch lines about the implant with changes in the radius of theimplant resulting from extension and retraction of the control arms. Ingeneral, one unit of radial change in the implant results inapproximately 2π units of circumferential change. Accordingly, worm gear7958, gear 7956, and spool 7944 are sized and configured such thatrotation of expansion shaft 7938 resulting in one unit of radialexpansion (or contraction) by the control arms results in approximately2π units of total cinch line payout (or retraction). Notably, inimplementations in which two or more cinch lines are included, the 2πunits of total cinch line payout or retraction may be distributed amongmultiple cinch lines. So, for example, in an implementation includingtwo cinch lines, worm gear 7958, gear 7956, and spool 7944 would beconfigured to impart approximately π units of payout/retraction of eachcinch line for each unit of radial expansion/contraction of the controlarms.

XXIII. Delivery Tool Handles for Sequenced Implant Release

Following delivery and placement of an implant using delivery devices ofthis disclosure, a clinician releases the implant from the distal end ofthe delivery device within the valve annulus.

FIGS. 83A-83H are photographs and corresponding schematic diagramsillustrating an example implant release sequence according to thisdisclosure. The sequence illustrated in FIGS. 83A-83H occurs subsequentto placement and implantation of implant 7950. Accordingly, while thefigures illustrate implant 7950 and delivery device 7900 in space, inpractice, implant 7950 would be implanted in the valve annulus andretained in position by its frame and retention features, such as barbsor hooks, of the frame.

FIG. 83A is a photograph of implant 7950 coupled to catheter assembly7904 and FIG. 83B is a proximal schematic view of implant 7950 at aninitial stage of releasing implant 7950 from catheter assembly 7904. Asshown in FIG. 83B, implant 7950 is supported on control arms (e.g.,control arm 7966) of delivery device 7900 and maintained on the controlarms by first cinch line 7962 and second cinch line 7964. Frictionand/or interference between mating portions of the control arms and theframe of the implant may further facilitate retention of implant 7950 onthe control arms.

Each cinch line is routed from a distal end of catheter assembly 7904about a portion of implant 7950 to a retention location. For example,first cinch line 7962 extends from a first cinch line tube 7968extending from catheter assembly 7904 and is routed about a first halfof implant 7950 to a retention location 7970. Similarly, second cinchline 7964 extends from a second cinch line tube 7972 about a second halfof implant 7950 to retention location 7970. As previously discussed inthis disclosure, routing of each of the cinch lines may include passingeach cinch line through a series of retention features distributed aboutthe frame of implant 7950 and/or the control arms. For example, asdescribed previously in this disclosure, such retention features mayinclude a series of circumferentially distributed eyelets or loopsconfigured to facilitate coupling of implant 7950 to the control arms ofdelivery device 7900 using one or more cinch lines.

In the state illustrated in FIG. 83B, first cinch line 7962 and secondcinch line 7964 meet at retention location 7970 and are held in place bya controllable retention element. In the implementation shown, thecontrollable retention element is a retention cable 7974 extending fromcatheter assembly 7904 to retention location 7970. At retention location7970, retention cable 7974 is threaded through loops or similar featuresat the terminal ends of first cinch line 7962 and second cinch line 7964to retain first cinch line 7962 and second cinch line 7964.

To initiate decoupling of implant 7950 from delivery device 7900, aclinician releases retention cable 7974 to free each of first cinch line7962 and second cinch line 7964 from retention location 7970. As shownin FIG. 82B, for example, releasing retention cable 7974 may includingproximally retracting or pulling retention cable 7974 into catheterassembly 7904.

This disclosure contemplates that a single cinch line may be used tocouple implant 7950 to delivery device 7900. In such implementations,the single cinch line extends around the full circumference of implant7950 and is retained, e.g., by retention cable 7974 or similar retentionmember, adjacent the same location where the cinch line first begins itscircumferential route around implant 7950.

This disclosure further contemplates that more than two cinch lines maybe included and routed in various ways about the implant and retained byone or more retention members/retention cables. For example, in theimplementation shown in FIG. 83A, first cinch line tube 7968 and secondcinch line tube 7972 open at approximately the same location such thatfirst cinch line 7962 and second cinch line 7964 are routed in oppositedirections about implant 7950. In an alternative implementation, firstcinch line tube 7968 and second cinch line tube 7972 may open atlocations offset by approximately 180 degrees (e.g., on opposite sidesof implant 7950) such that first cinch line 7962 and second cinch line7964 may be routed in the same direction (e.g., both clockwise or bothcounterclockwise) about implant 7950. Notably, in such cases, deliverydevice 7900 may include two retention members/retention cables with eachretention member retaining and retractable to release a respective oneof the cinch lines. In yet other example implementations, deliverydevice 7900 may include four cinch lines and four cinch line tubes. Inone such implementation, the cinch lines tubes may be offset by 90degrees and cinch lines extending from each cinch line tube may berouted in a common direction about a quarter of the implant. In suchimplementations, each cinch line may have a corresponding retentionmember retractable to release the cinch line.

In another four-tube/four-cinch line implementation, pairs of cinch linetubes may be disposed on opposite sides of implant 7950 with cinch linesextending from each tube about a quarter of implant 7950. So, forexample, distal outlets of two cinch line tubes may be located at a 12o′clock position of implant 7950 with a first cinch line routedclockwise from a first tube to a 3 o′clock position and a second cinchline routed from the 12 o′clock position to a 9 o′clock position. Distaloutlets of two additional cinch line tube may be disposed at a 6 o′clockposition of implant 7950 with one cinch line routed clockwise from the 6o′clock position to the 9 o′clock position and a second cinch linerouted counterclockwise from the 6 o′clock position to the 3 o′clockposition. The two cinch lines routed to the 9 o′clock position may thenbe retained by a first retention member while the two cinch lines routedto the 3 o′clock position may be retained by a second retention member.

The foregoing arrangement and routing principles may be expanded tosupport any suitable number of cinch lines and cinch line tubes with thecinch lines routed in either direction about implant 7950.

FIG. 83C is a photograph of implant 7950 coupled to catheter assembly7904 and FIG. 83D is a proximal schematic view of implant 7950 at asubsequent stage of release. Following initial retraction of retentioncable 7974 to release each of first cinch line 7962 and second cinchline 7964, each of the cinch lines may be similarly retracted intocatheter assembly 7904. As shown in FIGS. 83C and 83D, retracting eachof first cinch line 7962 and second cinch line 7964 may includeretracting or pulling each of the cinch lines into their respectivecinch line tubes (e.g., first cinch line 7962 into first cinch line tube7968 and second cinch line 7964 into second cinch line tube 7972).

In the specific implementation shown, retraction of retention cable7974, first cinch line 7962, and second cinch line 7964 is coordinatedsuch that first cinch line 7962 and second cinch line 7964 beginretraction prior to full retraction of retention cable 7974. In otherimplementations, retraction of first cinch line 7962 and second cinchline 7964 may be delayed until full retraction of retention cable 7974into catheter assembly 7904 or, more generally, any time subsequent toinitial retraction of retention cable 7974 and release of the cinchlines from retention location 7970.

FIG. 83E is a photograph of implant 7950 coupled to catheter assembly7904 and FIG. 83F is a proximal schematic view of implant 7950 at afurther stage of release. FIGS. 83E and 83F illustrate a stage in therelease operation prior to full retraction of first cinch line 7962 intofirst cinch line tube 7968 and second cinch line 7964 into second cinchline tube 7972. As shown, retention cable 7974 has been fully retractedinto catheter assembly 7904. Each of first cinch line 7962 and secondcinch line 7964 have also been substantially retracted into itsrespective tube. Accordingly, with the exception of the final framespoke and control arm pair adjacent the outlets of the cinch line tubes,implant 7950 is decoupled from delivery device 7900.

FIG. 83G is a photograph of implant 7950 and catheter assembly 7904 andFIG. 83H is a proximal schematic view of implant 7950 at a final stageof release. More specifically, each of first cinch line 7962 and secondcinch line 7964 are fully retracted and, as a result, implant 7950 is nolonger coupled to the control arms of delivery device 7900, asillustrated by the rotational offset between the control arms and framespokes shown in FIG. 83H.

In certain implementations, implant 7950 may be positively retained onthe control arms of delivery device 7900 following full retraction ofthe cinch lines. In such cases, the control arms of delivery device 7900may be decoupled from implant 7950 by a slight retraction of the controlarms, a rotation of the control arms, or another similar movement of thecontrol arms relative to implant 7950 which, as noted above, would beimplanted into and retained by tissue around the valve annulus duringthe release procedure. More generally, the fit between implant 7950 andcontrol arms is such that no or relatively minimal force is required todisengage implant 7950 from delivery device 7900 following removal ofthe cinch lines. To the extent that implant 7950 and delivery device7900 are designed to have positive retention without the cinch lines inplace, the corresponding fit between 7900 and elements of deliverydevice 7900 should be designed such that decoupling force issubstantially less than forces that would result in dislodging ofimplant 7950 from the valve annulus.

Following release, the control arms and any other components extendingfrom a distal end of catheter assembly 7904 may be retracted intocatheter assembly 7904 and/or sheathed in preparation for removal ofdelivery device 7900 from the patient.

In general, the foregoing process involves sequential steps ofretracting retention cable 7974 sufficiently to release first cinch line7962 and second cinch line 7964 then retracting each of first cinch line7962 and second cinch line 7964 to fully release implant 7950 fromdelivery device 7900. To ensure this sequence occurs in the proper orderand with proper timing, handle assemblies of delivery devices accordingto this disclosure may include a single control mechanism for retractingthe retention cables and cinch lines for release.

FIG. 84 is a proximal view of handle assembly 7902 of delivery device7900. As shown, handle assembly 7902 includes each of extension knob7914 and expansion knob 7936 for controlling extension and expansion ofimplant 7950 when implant 7950 is coupled to the distal end of deliverydevice 7900 during delivery and implantation.

FIG. 84 further illustrates a release mechanism in the form of a controlring 7976. As described below in further detail, control ring 7976 isrotatable to release implant 7950 from delivery device 7900. Morespecifically, rotation of control ring 7976 results in retraction ofretention cable 7974, first cinch line 7962, and second cinch line 7964(shown in the previous figures) in the correct sequence and with propertiming for release of 7950 from delivery device 7900. As shown in FIG.84 , control ring 7976 may be locked in position by a lock 7978 (e.g., alocking screw or similar locking mechanism that prevents rotation ofcontrol ring 7976) during delivery and placement of implant 7950. Onceimplant 7950 is positioned with in the valve annulus, lock 7978 may beunlocked to permit rotation of control ring 7976 and release of implant7950 from delivery device 7900.

Given mechanical conventions of counterclockwise rotation correspondingto retraction (e.g., for screws or similar threaded fasteners), examplesdiscussed in this disclosure generally rely on counterclockwise rotationof control ring 7976 to retract cinch lines and retention cables torelease of implant 7950 from delivery device 7900. Nevertheless, itshould be understood that the concepts taught in this disclosure can bereadily adapted into a configuration in which release results fromclockwise rotation of control ring 7976 instead.

Further details of the operation of control ring 7976 are now providedwith reference to FIGS. 85A-85C, which illustrate handle assembly 7902with housing 7916 removed. Referring first to FIG. 85A, handle assembly7902 includes a proximal member 7980 or frame element on which controlring 7976 is rotationally supported. Proximal member 7980 definesaperture 7982 through which release lines extend and that is generallyaligned with a ring orifice 7977 extending through control ring 7976. Inthe specific implementation shown, the release lines include a retentiontether 7984 and a cinch line tether 7986.

Retention tether 7984 is coupled to a proximal end of retention cable7974 (shown, e.g. in FIGS. 83B and 83D) such that proximally pullingretention tether 7984 results in retraction of retention cable 7974. Asdescribed above in the context of FIGS. 83A and 83B, retention cable7974 generally retains first cinch line 7962 and second cinch line 7964during implant delivery and deployment and retraction of retention cable7974 releases first cinch line 7962 and second cinch line 7964 forsubsequent detachment of implant 7950 from delivery device 7900.

Cinch line tether 7986 forms a loop about each of first cinch line 7962and second cinch line 7964 such that proximal pulling of cinch linetether 7986 results in retraction of each of first cinch line 7962 andsecond cinch line 7964. As noted above in the context of FIGS. 83C-83H,following release of first cinch line 7962 and second cinch line 7964 byretraction of retention cable 7974, retraction of first cinch line 7962and second cinch line 7964 generally causes the cinch lines to retractthrough coupling features (e.g., eyelets) configured to facilitateretention of implant 7950 on delivery device 7900, thereby allowingdetachment of implant 7950 from delivery device 7900.

The looping of cinch line tether 7986 about each of first cinch line7962 and second cinch line 7964 is more clearly illustrated in FIG. 85B,which is a detailed view of handle assembly 7902 in the area ofextension shuttle 7924. As shown, tether 7986 loops about and is used topull/retract each of first cinch line 7962 and second cinch line 7964simultaneously. However, in other implementations, separate tethers maybe included for each of first cinch line 7962 and second cinch line7964.

As previously noted, implementations of this disclosure may include morethan two cinch lines and/or more than a single retention element. Inimplementations including more than two cinch lines, cinch line tether7986 may be looped around or otherwise coupled to each of the cinchlines to perform simultaneously retraction of the cinch lines.Alternatively, the handle assembly may include multiple cinch linetethers coupled to approximately the same location on control ring 7976such that each of the cinch line tethers is pulled simultaneously. Asanother alternative, retraction of one or more cinch lines may bestaggered by coupling the cinch lines or corresponding cinch linetethers for each group to different locations about control ring 7976.

Similarly, in implementations with multiple retention elements, eachretention element may be coupled to a common retention element tetherthat, in turn, is coupled to and pullable by control ring 7976. By doingso, each of the retention elements may be simultaneously pulled byrotating control ring 7976. Alternatively, the retention elements ortethers coupled to subgroups of the retention elements may be coupled tolocations around control ring 7976 such that rotation of control ring7976 results in sequenced pulling of the retention elements. In general,however, the retention elements are sequenced to be retracted prior topulling of the cinch lines such that the cinch lines are released by theretention elements and able to be retracted.

FIG. 85C is a proximal view of handle assembly 7902 with housing 7916removed and further illustrating routing of retention tether 7984 andcinch line tether 7986. As shown, retention tether 7984 generallyextends along the longitudinal axis of handle assembly 7902 throughaperture 7982 and is coupled to a first attachment location 7988 oncontrol ring 7976. Cinch line tether 7986 similarly extends throughaperture 7982 and is coupled to a second attachment location 7990 oncontrol ring 7976, second attachment location 7990 being angularlyoffset from first attachment location 7988. Due to the coupling ofretention tether 7984 and cinch line tether 7986 to control ring 7976,rotation of control ring 7976 about and relative to proximal member 7980results in angular movement of retention tether 7984 and cinch linetether 7986 about aperture 7982. FIG. 85C further indicates a protrusion7992 (e.g., a spindle, hub, capstan, or similar structure) is coupled toand extends proximally from proximal member 7980 between control ring7976 and aperture 7982 in the path of retention tether 7984 and cinchline tether 7986 during rotation of control ring 7976.

FIGS. 86A-86D are schematic illustrations of the view shown in FIG. 85Cillustrating an example release sequence of implant 7950 from deliverydevice 7900 from the perspective of the release control. FIG. 86Aillustrates essentially the same configuration as FIG. 85C andcorresponds to a state prior to beginning a release process. As notedabove in the context of FIG. 85C, in this state, retention tether 7984and cinch line tether 7986 extend through aperture of proximal member7980 and couple to control ring 7976 at first attachment location 7988and second attachment location 7990, respectively. Protrusion 7992 ispositioned between aperture 7982 and control ring 7976 and along therotational path of the tethers.

FIG. 86B, illustrates handle assembly 7902 following a firstcounterclockwise rotation of control ring 7976. The state shown in FIG.86B corresponds to a stage in the implant release process followinginitial retraction of retention cable 7974 and which generallycorresponds to a state immediately after that shown in FIG. 83B. Morespecifically, the state shown in FIG. 86B occurs after initialretraction of retention cable 7974 but prior to retraction of firstcinch line 7962 and second cinch line 7964.

As shown in the transition between FIGS. 86A and 86B, rotation ofcontrol ring 7976 results in a corresponding rotation of firstattachment location 7988 for retention tether 7984 about aperture 7982.Rotation of first attachment location 7988 causes contact andinterference between retention tether 7984 and protrusion 7992 andcorresponding wrapping of retention tether 7984 around protrusion 7992.Protrusion 7992 functions like a pulley or post and increases the lengthof retention tether 7984 necessary to extend between aperture 7982 andfirst attachment location 7988. As a result, retention tether 7984 ispulled through aperture 7982 proximally pulling and retracting retentioncable 7974.

Rotation of control ring 7976 similarly results in a correspondingrotation of second attachment location 7990 for cinch line tether 7986about aperture 7982. However, in contrast to retention tether 7984,cinch line tether 7986 is not made to contact protrusion 7992 and thelength of cinch line tether 7986 extending between aperture 7982 andsecond attachment location 7990 remains constant. So, rotation ofcontrol ring 7976 as shown in the transition between FIGS. 86A and 86Bdoes not result in pulling of cinch line tether 7986 and first cinchline 7962 and second cinch line 7964 remain unretracted.

FIG. 86C illustrates handle assembly 7902 following further rotation ofcontrol ring 7976. In the illustrated state, cinch line tether 7986 isabout to but has not yet contacted protrusion 7992. As a result, thelength of cinch line tether 7986 extending from aperture 7982 to secondattachment location 7990 is the same as in FIGS. 86A and 86B andpulling/retraction of the cinch lines has not yet started. In contrast,the additional rotation of control ring 7976 has resulted in furtherpulling of retention tether 7984 to accommodate the increased distancebetween aperture 7982 and first attachment location 7988. As a result,the transition from the state shown in FIG. 86B to that shown in FIG.86C results in further pulling of retention tether 7984 and furtherretraction of retention cable 7974.

FIG. 86D illustrates handle assembly 7902 following even furtherrotation of control ring 7976. Again, this rotation results in furtherrotation of first attachment location 7988 and second attachmentlocation 7990 about aperture 7982. As in the previous figures, furtherrotation of first attachment location 7988 results in additional pullingof retention tether 7984 and further retraction of retention cable 7974due to the contact between retention tether 7984 and protrusion 7992.Rotation of control ring 7976 from the state shown in FIG. 86C to thatof FIG. 86D also results in contact between cinch line tether 7986 andprotrusion 7992 and initiating pulling of cinch line tether 7986 throughaperture 7982. Given the looping of cinch line tether 7986 about firstcinch line 7962 and second cinch line 7964, the pulling of cinch linetether 7986 results in retraction of first cinch line 7962 and secondcinch line 7964.

With retention tether 7984 and cinch line tether 7986 now in contactwith protrusion 7992, further rotation of control ring 7976 results infurther retraction of retention cable 7974, first cinch line 7962, andsecond cinch line 7964. In certain implementations, handle assemblycontrol ring 7976 may include a stop, indicators, or similar features toindicate when control ring 7976 has been sufficiently rotated tosufficiently retract each of retention cable 7974, first cinch line7962, and second cinch line 7964 to release implant 7950 from deliverydevice 7900.

As shown in FIGS. 86A-86D, sequential retraction of retention cable 7974followed by the cinch lines is achieved by rotation of control ring 7976triggering pulling of retention tether 7984 followed by cinch linetether 7986. More specifically, rotation of control ring 7976 in arelease direction first causes retention tether 7984 to contactprotrusion 7992, initiating pulling of retention tether 7984 andretention cable 7974. Subsequent rotation of control ring 7976eventually causes contact between cinch line tether 7986 and protrusion7992, initiating pulling of cinch line tether 7986 and the cinch lines.

This disclosure contemplates that the timing and sequencing for pullingof the retention components and the cinch line components can bemodified in various ways. For example, by changing the angular offsetbetween the attachment locations on control ring 7976 for retentiontether 7984 and cinch line tether 7986, sequencing of cinch line pullingrelative to retention cable pulling can be modified. In general,increasing the angular offset between the attachment locations resultsin pulling of the cinch lines initiated later in the process ofretracting the retention cable. Conversely, decreasing the angularoffset between the attachment locations results in retraction of thecinch lines beginning earlier in the process of retracting the retentioncable. Protrusion 7992 may also be modified to change timing andsequencing of the release operation. For example, the rate at which thetethers are pulled per unit of rotation of control ring 7976 isgenerally a function of the size of protrusion 7992. As a result,increasing or decreasing the circumference/perimeter of protrusion 7992can be used to increase or decrease the rate at which the tethers arepulled (all other things being equal).

XXIV. Structural Mounting of Delivery System

FIGS. 77A-78C illustrate implant delivery system 7700, which includesdelivery device 7702 and mounting assembly 7704. As described in thecontext of those figures, mounting assembly 7704 is generally configuredto support delivery device 7702 and may include various features forcontrolled operation of delivery device 7702. For example, FIGS. 77A and77B illustrate longitudinal translation of delivery device 7702 relativeto mounting assembly 7704 by rotation of knob 7712 to performinsertion/retraction of delivery device 7702. FIGS. 78A-78C similarlyillustrate manual rotation of delivery device 7702 within mountingassembly 7704. Additional details regarding mounting assemblies areprovided below with specific reference to FIGS. 87A-87L, whichillustrate mounting assembly 8700 and various components of mountingassembly 8700. Mounting assembly 8700 is substantially like mountingassembly 7704 of FIGS. 78A-78C, so unless otherwise stated, thedescription of mounting assembly 7704 provided earlier in thisdisclosure is generally applicable to mounting assembly 8700.

FIG. 87A is an isometric view of a mounting assembly 8700 according tothe present disclosure. Mounting assembly 8700 includes a structuralcoupling 8702, an arm assembly 8710, and a handle mount assembly 8730.FIG. 87A further includes a handle assembly element 8701 and astructural element 8703.

As shown, mounting assembly 8700 is coupled to and supported bystructural element 8703. More specifically, structural coupling 8702couples to structural element 8703 with arm assembly 8710 coupled to andextending from structural coupling 8702. Arm assembly 8710 may be anysuitable structure for supporting and adjusting the position andorientation of handle mount assembly 8730. As shown, arm assembly 8710is a universal articulating arm structure including multiple manipulableand lockable joints. This disclosure contemplates that other supportstructures may be used to support and maintain position of handle mountassembly 8730 during use, arm assembly 8710 is included as a specificexample that includes degrees of freedom and flexibility that areconducive to use with delivery devices of this disclosure.

Handle mount assembly 8730 is coupled to and extends from arm assembly8710. During use, handle mount assembly 8730 receives and providesdirect support of a delivery device, as reflected by handle assemblyelement 8701. As noted in the context of 77A-78C and as furtherdiscussed below, handle mount assembly 8730 may further include elementsfor facilitating insertion and rotation of a delivery device whilemaintaining a longitudinal axis of the delivery device in a fixedlocation.

In general, handle assembly element 8701 corresponds to a portion of adelivery device according to this disclosure. More specifically, handleassembly element 8701 corresponds to a handle assembly of a deliverydevice and is provided in the figures to illustrate how delivery devicesof this disclosure are received and supported by mounting assembly 8700.This disclosure contemplates that each of handle assembly element 8701may vary and, as such, handle assembly element 8701 is intended only asa non-limiting example of a delivery device structure that may bereceived and supported by mounting assembly 8700.

Structural element 8703 is intended to reflect an environmentalstructure, such as a bed rail, to which mounting assembly 8700 may becoupled and that supports mounting assembly 8700. Like handle assemblyelement 8701, structural element 8703 is provided as a non-limitingexample of a structure to which mounting assembly 8700 may be coupled.Accordingly, any specific aspects of structural element 8703 shown inthe figures should be considered non-limiting. For example, thisdisclosure contemplates that structural element 8703 may vary in sizeand shape from that shown in the figures or that mounting assembly 8700may be coupled to structures other than bed rails, including standalonemounting systems that do not rely on other capital equipment within theoperating theater.

FIG. 87B is an isometric view of handle mount assembly 8730 and aterminal portion of arm assembly 8710 including an interface block 8774.Handle mount assembly 8730 includes a carriage assembly 8732 coupled toand movable along a rail assembly 8750. Rail assembly 8750 includes arail 8752 and a frame 8754. Carriage assembly 8732 and rail assembly8750 are selectively coupled to arm assembly 8710 by an interface 8770.Interface 8770 includes a rail-side interface element in the form of aplate 8772 that is receivable by interface block 8774. As shown,interface block 8774 further includes a locking control 8776 in the formof a lever that can be selectively engaged and disengaged to fix andrelease plate 8772 from interface block 8774, thereby permittingselective attachment and removal of handle mount assembly 8730 from armassembly 8710. FIG. 87B further includes an extension member 8778coupled to and extending from interface block 8774 and that couplesinterface block 8774 to the remainder of arm assembly 8710. In general,extension member 8778 is configured to mate with and to be coupled witha terminal end of arm assembly 8710.

In the implementation shown, carriage assembly 8732 includes a manuallydriven stepper-type drive system. More specifically, carriage assembly8732 is retained on rail assembly 8750 by a dove-tail type matingarrangement. Carriage assembly 8732 includes knobs (such as knob 8740)that are rotatable to provide controlled translation of carriageassembly 8732 along rail assembly 8750. For example, knob 8740 may becoupled to an internal gear or cog of carriage assembly 8732 that mateswith rail 8752 of rail assembly 8750 such that rotation of knob 8740rotates the internal gear or cog and drives carriage assembly 8732 alongrail 8752.

FIG. 87C is a detailed isometric view of rail assembly 8750. Morespecifically, FIG. 87C illustrates a distal portion of rail 8752 andframe 8754. As shown, rail assembly 8750 may have an open end 8751 tofacilitate attachment and removal of carriage assembly 8732 from railassembly 8750. In certain implementations, rail assembly 8750 mayinclude a retention feature, such as stop 8753 that generally retainscarriage assembly 8732 on rail 8752, but that can be selectivelydisengaged to permit sliding of carriage assembly 8732 off rail 8752 atopen end 8751. For example, stop 8753 is generally biased into theconfiguration shown in FIG. 87C to retain carriage assembly 8732 on rail8752; however, stop 8753 may be depressed, removed, or otherwisedisengaged to permit sliding of carriage assembly 8732 off open end8751. Referring to FIG. 87B, frame 8754 is shown as further including anoptional stop 8756 protruding from a proximal portion of frame 8754 andthat limits proximal travel of carriage assembly 8732 along rail 8752.

FIGS. 87D and 87E isometric views of rail assembly 8750, carriageassembly 8732 and interface 8770 in a decoupled state. As shown in FIG.87D, plate 8772 is coupled to an underside of frame 8754 and includes aretention structure 8773. Interface block 8774 includes a face 8779shaped to receive retention structure 8773 (e.g., having a groove orchannel shaped to the correspond to the exterior surface of the U-shapedretention structure) and further includes a locking pillar 8775 shapedto be received within an internal channel 8777 defined on an innersurface of retention structure 8773. As specifically shown in FIG. 87D,retention structure 8773 is in the form of a U-shaped channel with agroove or channel extending along the inner surface of the U-shapedstructure. During operation, locking pillar 8775 is manipulable toselectively engage internal channel 8777 to lock interface block 8774 toplate 8772.

FIGS. 87G and 87H illustrate interface block 8774 in an open/unlockedstate and a closed/locked state, respectively. In the illustratedimplementations, interface block 8774 transitions between theopen/unlocked state of FIG. 87G to the closed/locked state of FIG. 87Hin response to actuation of locking control 8776. As shown, lockingcontrol 8776 is in the form of a cam-style lever that drives lockingpillar 8775 between a raised position (shown in FIG. 87G) and aretracted position (shown in FIG. 87H). In operation, plate 8772 is slidonto interface block 8774 while locking pillar 8775 is in the openconfiguration shown in FIG. 87G. More specifically, plate 8772 is slidonto interface block 8774 such that a lip 8771 of locking pillar 8775 isreceived within internal channel 8777 of retention structure 8773.Locking control 8776 is then actuated to retract locking pillar 8775into interface block 8774, thereby locking interface block 8774 to plate8772.

Among other advantages, the specific coupling arrangement illustrated inFIGS. 87D and 87E can facilitate maintaining a sterile operatingenvironment. FIGS. 87H and 871 , for example, are perspective views ofmounting assembly 8700 with and without carriage assembly 8732 coupledto interface block 8774. As shown in the figures, interface block 8774and arm assembly 8710 may be covered in a sterile drape 8781 such thatbetween surgeries carriage assembly 8732 and rail assembly 8750 may bereadily detached from arm assembly 8710 for disposal or sterilizing.With carriage assembly 8732 and arm assembly 8710 removed, a used drapecan be readily slid off arm assembly 8710 and replaced with a new,sterile drape, thereby eliminating or reducing the need to re-sterilizethe underlying arm assembly 8710.

FIGS. 87J and 87K are isometric views of carriage assembly 8732. Morespecifically, FIG. 87J illustrates carriage assembly 8732 including ayoke 8712 and retaining handle assembly element 8701. FIG. 87Killustrates carriage assembly 8732 with yoke 8712 removed to better showa rotating collar 8738.

As previously discussed, carriage assembly 8732 includes a knob 8740rotatable to drive carriage assembly 8732 along rail 8752 of railassembly 8750. Such translation of carriage assembly 8732 can be used tocontrol insertion of a delivery device coupled to mounting assembly8700. Implementations of this disclosure may also enable rotation of thedelivery device relative to carriage assembly 8732. For example, as mostclearly shown in FIG. 87K, carriage assembly 8732 may include a rotatingcollar 8738. Rotating collar 8738 is coupled to and supported by a body8742 of carriage assembly 8732 and is rotatable relative to body 8742about a longitudinal axis 8744, which corresponds to a longitudinal axisof the delivery device when retained by carriage assembly 8732. In atleast some implementations, rotation of rotating collar 8738 may beguided by a slot 8746 or similar guide element of rotating collar 8738that mates with a corresponding structure of body 8742 (not shown). Anexample of such rotation is shown in FIGS. 78A-78C, which illustraterotation of delivery device 7702 within cradle 7706. As further shown inFIGS. 87J and 87K, carriage assembly 8732 may include a rotational lock(e.g., locking knob 8739) configured to selectively lock and unlockrotating collar 8738 in position.

In at least certain implementations, carriage assembly 8732 may beconfigured to facilitate discrete rotation of rotating collar 8738. Forexample, FIG. 87L is a detailed view of carriage assembly 8732 aspresented in FIG. 87L. As shown, rotating collar 8738 includes aproximal face 8741 that further includes a series of detents (e.g.,detent 8743). Carriage assembly 8732 may include one or morecorresponding protrusions (not shown) such that as a clinician oroperator rotates rotating collar 8738, rotating collar 8738 transitionsbetween discrete rotational positions due to engagement of theprotrusion with the detents.

FIG. 87M is an isometric view of yoke 8712, which, as illustrated inFIG. 871 , is coupled to and retained by rotating collar 8738 whencarriage assembly 8732 is fully assembled. As shown in FIG. 87M, yoke8712 includes a lower member 8714 and an upper member 8716 coupled tolower member 8714 by a hinge 8718 or similar joint. Each of lower member8714 and upper member 8716 are generally shaped to conform to andreceive a portion of a delivery tool, e.g., as shown in the previousfigures by retention of assembly element 8701 by yoke 8712. Althoughthis disclosure contemplates other styles of closure mechanisms, yoke8712 includes a cam-style latching mechanism 8720 configured to clampupper member 8716 relative to lower member 8714 and about the deliverydevice.

FIG. 87N is an isometric view of structural coupling 8702 and structuralelement 8703. As previously noted, structural coupling 8702 iscoupleable to structural element 8703 or other capital equipment withinan operating environment to support mounting assembly 8700. Asillustrated, structural coupling 8702 includes a body 8704 shaped toreceive or otherwise mate with structural element 8703. Structuralcoupling 8702 further includes a locking or retention mechanism (e.g.,locking knob 8706) adapted to affix structural coupling 8702 tostructural element 8703 once positioned on structural element 8703.

Mounting assembly 8700 is intended to illustrate one example mountingstructure suitable for use with delivery devices of this disclosure.This disclosure contemplates that the various components and features ofmounting assembly 8700 illustrated in the figures and discussed abovecan be replaced or modified with one or more other alternativecomponents. For example, arm assembly 8710 may be substituted with anyother suitable articulating or non-articulating assembly capable ofsupporting delivery devices of this disclosure in position relative to apatient. Similarly, while mounting assembly 8700 is illustrated asincluding structural elements for providing controlled insertion androtation of delivery devices, either functionality may be omitted. Asanother example, mounting assembly 8700 includes cam-style lockingmechanisms for several components. Such locking mechanisms are generallyeasy and intuitive to articulate in a surgical context; however, otherlocking mechanisms may be used in their place. For example, yoke 8712 isillustrated in FIG. 87K as including a cam-style latching mechanism8720; however, cam-style latching mechanism 8720 may be readilysubstituted with a screw-type lock, a magnetic latch, a tie down, orother suitable mechanism.

XXV. Control Arm Assembly Including Cantilevered Control Arms

FIGS. 56-58 illustrate an example implementation of a delivery device3600 according to the present disclosure and described in furtherdetail, above. As shown in those figures, delivery device 3600 generallyincludes a control arm assembly 3608 at distal portion 3636 of deliverydevice 3600. Control arm assembly 3608 includes multiple control armpairs distributed around an extension member 3606. Extension member 3606is selectively extendable and retractable relative to delivery catheter3604 to facilitate deployment of implant 3800.

Each control arm pair of control arm assembly 3608 includes a proximalarm 3634 coupled to a respective distal arm 3640. During operation, acontrol shaft disposed within delivery catheter 3604 and coupled to aproximal end of each of the proximal control arms of control armassembly 3608 is translatable to selectively extend and retract theproximal control arms. As the proximal control arms are extended,diverter 3628 directs the proximal arms in a lateral and outwarddirection. Due to the coupling of the distal control arms to theirrespective proximal control arms, this lateral extension of the proximalcontrol arms results in similar lateral and outward movement of thedistal control arms, thereby expanding control arm assembly 3608. Suchexpansion of control arm assembly 3608 causes similar expansion ofimplant 3800, which is generally coupled to and supported by control armassembly 3608 during delivery and implantation. Collapse of the implantcan be similarly achieved by retracting the control shaft, whichretracts the proximal control arms, laterally contracts the coupling ofthe distal and proximal control arms, and collapses control arm assembly3608, thereby collapsing implant 3800.

As shown in FIGS. 57 and 58 , each of the control arm pairs of deliverydevice 3600 generally include a proximal control arm, e.g., proximal arm3634, and a respective distal control arm, e.g., distal arm 3640. Morespecifically, and with reference to FIG. 58 , proximal portion 3641 ofdistal arm 3640 is coupled to distal portion 3636 of proximal arm 3634by a T-and-slot style joint in which a T-shaped protrusion 3637 ofproximal arm 3634 is inserted through and subsequently rotated to beretained by aperture 3639 of distal arm 3640. Notably, the coupling ofdistal arm 3640 and proximal arm 3634 in delivery device 3600 is at ornear the end of the control arms.

Among other advantages, the control arm coupling and arrangement ofdelivery device 3600 and control arm assembly 3608 results in asubstantially maximum moment arm for distal arm 3640 and efficienttransfer of forces applied to proximal arm 3634 (e.g., by translatingthe control shaft) to distal arm 3640. As illustrated in FIG. 56 ,however, coupling the distal end of the proximal control arms at or nearthe proximal ends of the distal control arms generally limits the degreeto which control arm assembly 3608 may be retracted during delivery andimplantation. For example, FIG. 56 illustrates delivery device 3600 in afully collapsed and fully or near fully retracted state. Furtherretraction of control arm assembly 3608 into delivery catheter 3604 fromthe state shown in FIG. 56 generally results in interference betweencontrol arm assembly 3608 and the distal end of delivery catheter 3604,precluding further retraction.

Since the control arm assembly is a generally rigid body and protrudesfrom the distal end of the delivery catheter, the degree to which thecontrol arm assembly can retract relative to the delivery cathetercontributes to the general maneuverability of the implant duringdelivery and implantation. More specifically and all other things beingrelatively equal, a control arm assembly that is further retractableinto the delivery catheter will reduce the non-steerable length at thedistal end of the delivery device, improving the maneuverability of thedistal end and, by extension, an implant coupled to the distal end.

With the foregoing in mind, FIG. 88A-89 illustrate an alternativeconfiguration of a delivery device 8800 including a control arm assembly8802 for selectively expanding and collapsing an implant 8850 and thatis extendible from a delivery catheter 8804. In contrast to control armassembly 3608 of delivery device 3600, in which coupling of the controlarm pairs is positioned near the ends of the proximal and distal controlarms, control arm assembly 8802 includes control arm pairs in whichcoupling of the proximal control arm and the distal control arm ispositioned away from the end of the distal control arm such that aportion of the distal control arm is cantilevered. This configurationenables further retraction of control arm assembly 8802 into deliverycatheter 8804 during delivery as compared to control arm assembly 3608,improving maneuverability of the distal end of delivery catheter 8804and facilitating improved positioning and orientation of implant 8850.

FIG. 88A is a proximal perspective view of a distal end 8801 of deliverydevice 8800 with implant 8850 coupled to control arm assembly 8802. Forclarity, delivery catheter 8804 is shown in FIG. 88A in dashed lines andoccluder and outer skirt of implant 8850 are omitted. Control armassembly 8802 is coupled to and distributed about an extension member8806, which is selectively extendible from and retractable into deliverycatheter 8804. So, for example, delivery catheter 8804 will generally bekept in a fully or near fully retracted state during delivery of theimplant to minimize the unsteerable distal length of delivery device8800. Following approximate placement of implant 8850, extension member8806 is extended (in conjunction with retraction of a sheath (not shown)extending about the distal end of delivery device 8800) from deliverycatheter 8804, deploying implant 8850 and permitting expansion ofimplant 8850 prior to final positioning/orientation and placement withinthe valve annulus.

As illustrated and as previously discussed in other sections of thisdisclosure, implant 8850 is coupled to control arm assembly 8802 by afirst cinch line 8852 and a second cinch line 8854 that extend from afirst cinch line tube 8856 and a second cinch line tube 8858,respectively, about a circumference of implant 8850. Implant 8850includes eyelets (e.g., eyelet 8859) that extend proximally throughslots formed in the distal control arms of control arm assembly 8802with each of the cinch lines routed through the eyelets on a proximalside of the control arms, e.g., as illustrated in FIG. 73B. Each offirst cinch line 8852 and second cinch line 8854 are held in position bya retention member 8860 that is retractable into delivery catheter 8804through extension member 8806 to allow for retraction of first cinchline 8852 and second cinch line 8854 and release of implant 8850 fromcontrol arm assembly 8802.

FIG. 88B is the same perspective of FIG. 88A, albeit with implant 8850and the cinch line-related elements of delivery device 8800 removed forclarity while FIG. 88C is a side elevation view of control arm assembly8802. With reference to FIGS. 88B and 88C, control arm assembly 8802generally includes a series of control arm pairs distributed aboutextension member 8806. In the specific example of delivery device 8800,control arm assembly 8802 includes six control arms pairs distributed at60-degree offsets; however, other implementations of this disclosure mayinclude more or fewer control arm pairs with different distributions.

Each control arm pair includes a proximal control arm, e.g., proximalcontrol arm 8808, coupled to a respective distal control arm, e.g.,distal control arm 8810. As shown in FIGS. 88D and 88E, coupling ofproximal control arm 8808 to distal control arm 8810 may be based on aT-and-slot type coupling like the coupling arrangement discussed abovein the context of FIG. 58 . More specifically, proximal control arm 8808includes a T- or I-shaped protrusion 8812 that is inserted through acorresponding aperture 8814 of distal control arm 8810 and rotated suchthat distal control arm 8810 is retained by protrusion 8812 andresulting in a coupling 8816 connecting proximal control arm 8808 anddistal control arm 8810 in a hinge-like manner. Notably, coupling 8816is disposed at a location distal a proximal end 8818 of distal controlarm 8810 such that proximal end 8818 extends beyond coupling 8816 andforms a cantilevered section 8820 of distal control arm 8810.

Referring to FIG. 88B, the proximal control arm of each control arm pairof control arm assembly 8802 may be coupled to or driveable by a controlshaft 8824 disposed within delivery catheter 8804. More specifically, asdelivery catheter 8804 is translated distally, the proximal control armsare made to extend distally and radially outward (e.g., due to beingdirected outwardly by a diverter 8826). As the proximal control armsextend radially outward, they push the distal control arms outward aswell, thereby expanding control arm assembly 8802. Conversely, ifcontrol arm assembly 8802 is in an expanded state and control shaft 8824is proximally translated, the proximal control arms of control armassembly 8802 are retracted and radially collapsed, resulting incorresponding radially collapse of the distal control arms to which theproximal control arms are coupled.

FIG. 88F illustrates proximal control arm 8808 and distal control arm8810 in further detail with certain dimensions indicated. As shown inFIG. 88E, when fully expanded, distal control arm 8810 extends a lengthL2 relative to a longitudinal axis 8822 of delivery device 8800. Incertain implementations, L2 may be from and including about 20 mm to andincluding about 40 mm. For example, L2 may be about 27 mm. In contrast,coupling 8816 is located at a length L3 relative to longitudinal axis8822. In certain implementations, L3 may be from and including about 15mm to and including about 20 mm, but not greater than L2. For example,L3 may be about 20 mm. More generally, L3 may be based on a relationshipto L2. For example, in certain implementations L3 may be positioned at alocation that is approximately within a central two-thirds of L2. Asanother example, L3 may be from and including about 40% to and includingabout 90% of L2. For example, L3 may be about 75% of L2.

As shown in FIG. 88F, each of the distal control arms may includevarious curved sections such that the distal control arms generallyconform to other elements of delivery device 8800 when the distalcontrol arms are in a collapsed state. For example, distal control arm8810 includes each of a distal bend 8828, a medial bend 8830, and aproximal bend 8832 adapted to conform distal control arm 8810 toextension member 8806 and delivery catheter 8804.

FIG. 89 is a perspective view of delivery device 8800 with control armassembly 8802 in a collapsed state, as shown, distal control arm 8810 iscoupled to proximal control arm 8808 and is shaped to generally conformto extension member 8806 and delivery catheter 8804. More specifically,distal bend 8828 of distal control arm 8810 directs a first portion ofdistal control arm 8810 toward and along extension member 8806. Medialbend 8830 then directs a medial section of distal control arm 8810radially outward and around a tip 8834 of delivery catheter 8804.Finally, proximal bend 8832 redirects distal control arm 8810 radiallyinward toward or parallel to delivery catheter 8804. Stated differently,the various curves of distal control arm 8810 result in a shape ofdistal control arm 8810 that generally conforms to the distal end of thevarious components of delivery device 8800. Notably, the shape of distalcontrol arm 8810 enables retraction of control arm assembly 8802 suchthat a proximal extend of control arm assembly 8802 is positionedproximally beyond a distal end of delivery catheter 8804, reducing thenon-steerable length of delivery catheter 8804. In at least certainimplementations, the curved shape of distal control arm 8810 alsoresults in a bulbous shape, particularly when sheathed, that is readilynavigable through physiological lumens of the patient.

XXVI. Alternative Example Implantation Process

To provide additional detail and context for the various featuresdescribed in the preceding sections, FIG. 90 is a block diagramillustrating a method 9000 for implanting an implant using deliverydevice, each of the implant and delivery device according to variousaspects of this disclosure.

At step 9002, the implant and the delivery device are prepared for theimplantation process. In general, preparation of the implant on thedelivery device includes coupling the implant to a distal end of thedelivery device, inserting the implant into a sheath/delivery catheterof the delivery device, and mounting the delivery device within theoperating theater.

As described throughout this disclosure, coupling of the implant to thedelivery device generally includes routing one or more cinch about theimplant in a manner that couples the implant to a control arm assemblyof the delivery device. For example, as illustrated in FIG. 73B, theimplant may include circumferentially distributed eyelets (e.g., eyelet6802) that extend proximally through both a frame (e.g., frame 6355) ofthe implant and control arms (e.g., control arm 7308) of the control armassembly such that an aperture (e.g., cinch line hole 6810) of theeyelet is positioned proximal both the frame and control arm. A cinchline is then routed through the aperture and fixed (e.g., using aretractable retention member), thereby coupling the implant to thecontrol arm assembly. FIG. 59 illustrates an alternative implementationin which cinch lines are routed through rings coupled to each of controlarms of the control arm assembly and the implant frame such that cinchlines run through the rings similarly couples the implant to the controlarm assembly.

In at least some implementations, coupling of the implant to thedelivery device may also be facilitated through mating of correspondingelements of the implant and the control arm assembly. For example,referring back to FIG. 73B, eyelet 6802 may be sized and shaped to bepress fit through slot 7312 of control arm 7308, thereby providingadditional positive retention of the implant on the control armassembly.

Coupling of the implant to the delivery device is generally performedwith the delivery device in an extended position. For example, aspreviously discussed, the delivery device generally includes an internaltubular member coupled to the control arm assembly and that islongitudinally translatable relative to the delivery catheter of thedelivery device. During delivery and implantation, such extension andretraction facilitates positioning and orientation of the implantwithout requiring substantial steering or insertion of the deliverycatheter. Accordingly, during preparation of the delivery device andimplant, the delivery device may be placed in a fully or partiallyextended state. following coupling of the implant to the control armassembly of the delivery device, the implant may be radially compressedand the control arm assembly retracted such that the implant ispartially retracted into the delivery catheter and/or is coverable by anextendible sheath of the delivery device.

With the implant coupled to the delivery device and sheathed, thedelivery device may be coupled to a mount assembly, such as the mountassembly described above in the context of FIGS. 87A-87N.

As noted in the context of FIGS. 87H and 871 , preparation of theimplant and delivery device may also include preparation of the mountingassembly on which the delivery device is supported, such as bysterilizing and/or applying a sterile drape to the mounting assemblyprior to coupling the delivery device to the mounting assembly.

At step 9004, the implant is delivered to a patient atrium, e.g., via anantegrade percutaneous route (e.g., a trans-femoral or trans-jugularroute). Navigating the delivery device and implant to the implantationsite may include routing the delivery device along a guidewirepreviously inserted into the patient and extending to the atrium.

Navigating the delivery device and implant may include one or more of acombination of steering the delivery catheter of the delivery device,modifying insertion of the delivery device, modifying rotation of thedelivery device, or any similar movement and manipulation of thedelivery device. In certain implementations, at least some of themaneuverability of the delivery catheter and the delivery device may beprovided by insertion and rotation control elements of the mountingassembly to which the delivery device is attached. For example, themounting assembly of FIGS. 87A-87N includes a stepper-type control knobthat may be rotated to control insertion of the delivery device and amanually rotatable collar that can be rotationally indexed to modify arotation of the delivery device.

As noted, navigating the implant may also include steering the deliverycatheter of the delivery device. In certain implementations, thedelivery catheter may include multiple steerable sections. For example,in the specific example illustrated in FIGS. 45A-45H, delivery catheter3604 includes a distal steerable section 4502 and a proximal sectionproximal steerable section 4504 with distal steerable section 4502steerable along a first plane and proximal steerable section 4504steerable along each of the first plane and a second plane orthogonal tothe first plane (both relative to delivery catheter 3604 being in aneutral steering configuration). As described and illustrated in thecontext of FIG. 46 , steering may be achieved in certain implementation,by a collection of levers disposed at the handle assembly of thedelivery device with each handle manipulable to control steering of acorresponding section of the delivery catheter along a specific plane.

Step 9006 includes retracting the sheath extending around the distal endof the delivery device, including the implant, to facilitate subsequentdeployment of the implant. As discussed in previous sections, retractingof the sheath may include manipulating a corresponding control of thedelivery device handle assembly to proximally translate the sheathrelative to the delivery catheter, thereby exposing the distal end ofthe delivery device and the implant.

Step 9008 includes deploying the implant. Deploying the implantgenerally refers to the process of clearing the implant from the sheathand the distal end of the delivery catheter such that the implant can befreely expanded, collapsed, and positioned for implantation.

In at least certain implementations, clearing the implant from thesheath and the distal end of the delivery catheter may include distallyextending the implant relative to the delivery catheter. For example,FIGS. 79A-80B illustrate an example handle assembly mechanism configuredto longitudinally translate the implant relative to the deliverycatheter. More specifically, the handle assembly shown includes arotatable knob that drives an internal shuttle of the handle assembly.The shuttle, in turn, is coupled to an extension shaft that extendsthrough the delivery catheter and terminates in the control arm assemblyto which the implant is coupled. Operating the rotatable knob translatesthe shuttle within the handle assembly, thereby driving the extensionshaft and, as a result, the control arm assembly and implant. As notedin FIG. 74-76D, in at least certain implementations, the extensionmember may include sections of selectively modified flexibility suchthat the extension shaft does not substantially impact the steerabilityof the delivery catheter within which the extension shaft extends.

Deploying the implant may further include expanding the implantfollowing clearance of the sheath and the delivery catheter. Asdescribed in the context of FIGS. 81A-82C, expansion of the implant maybe performed by rotation of an expansion control, e.g., a rotatableknob, of the handle assembly. In one specific implementation, expansionis achieved by actuation (e.g., rotation) of the expansion control,which results in simultaneous proximal translation of a control armshaft and corresponding payout of the cinch lines coupling the controlarm assembly to the implant. Proximal translation of the control armshaft causes the control arm pairs of the control arm assembly to expandlaterally. Given the coupling of the implant to the control arm assemblyand the biasing of the implant into expansion, expansion of the controlarm assembly drives and/or permits natural expansion of the implant intoan expanded state. Notably, payout of the cinch lines is generallycoordinated by the handle assembly such that the cinch lines aremaintained in tension as the implant expands. Doing so improves theuniformity with which the implant expands while improving theresponsiveness of the implant to actuation of the expansion controls.

Step 9010 includes retracting/de-extending the implant relative to thedelivery catheter following at least partial expansion of the implant instep 9008. Among other things, such retraction of the implant relativeto the delivery catheter reduces the non-steerable length at the distalend of the delivery device. With less non-steerable length, the implantcan be more readily and accurately manipulated within the atrium tofacilitate proper alignment of the implant with the valve annulus. Incertain implementations, the retraction of step 9010 may be performed byreversing the extension mechanism discussed above in the context of step9008. So, for example, the extension control (e.g., the rotatable knobcorresponding to extension) of the handle assembly may be actuated in anopposite direction to proximally retract the shuttle of the handleassembly. Doing so also retracts the extension shaft, thereby retractingthe now-expanded implant relative to the delivery catheter.

Step 9012 includes positioning the implant for final implantation. Amongother things, such positioning may include aligning or approximatelyaligning a longitudinal axis of the implant with a valve axis normal tothe valve annulus. Positioning the implant may further include adjustingthe height of the implant relative to the valve annulus such that anoccluder of the implant is positioned to interact with or otherwisecontact the native leaflets of the patient valve. Positioning theimplant may include additional expanding, collapsing, and/or moving ofthe implant to achieve proper positioning of the implant relative to thevalve annulus. Moving of the implant may include, without limitation,one or more of changing rotation and insertion of the delivery device,steering of the delivery catheter, and extending/retracting the implantrelative to the delivery catheter, as described in previous steps.

Step 9014 includes fully expanding the implant once in position forimplantation. As noted above in the context of step 9008, expanding theimplant generally includes operating an expansion control of the handleassembly that simultaneously expands the control arm assembly to whichthe implant is coupled and pays out the cinch line extending around theimplant. By fully expanding the implant, within the valve annulus, theimplant is made to interfere with and engage cardiac tissue. Forexample, the implant may include outwardly protruding prongs or tinesshaped and positioned to engage tissue adjacent the valve during theexpansion process.

Step 9016 includes releasing the implant from the delivery device bydecoupling the implant from the control arm assembly of the deliverydevice. A full description of an example release process andcorresponding handle mechanisms for achieving release of the implant aredescribed above in the context of FIGS. 83A-86D. In general, however,certain release processes include coordinate release and retraction ofthe cinch lines coupling the implant to the control arm assembly. Forexample, in certain implementations, the handle assembly includes acontrol element (e.g., a rotating ring) that, when actuated first pullsone or more retention members that pin the cinch lines extending aroundthe implant in position. Further rotation of the control element theninitiates pulling of the cinch lines into the delivery catheter, therebydecoupling the control arm assembly and the implant. In implementationsin which the control arm assembly and implant are further coupled by apress fit or similar loose-fitting joint, full release of the implantfrom the control arm assembly/delivery device may further includeretracting the control arm assembly (e.g., by operating the extensionmechanism to retract the control arm assembly) or by applying a similarproximal force on the control arm assembly (e.g., by retracting orrotating the delivery device, steering the delivery catheter, orperforming a similar actuation of the delivery device).

Step 9018 includes preparing the delivery device for retraction andremoval from the patient. In general, preparation of the delivery deviceincludes fully collapsing and retracting the control arm assembly andre-sheathing the distal portion of the delivery device. Finally, at step9020, the delivery device may be removed from the patient. In certaincases, removal of the delivery device from the patient includes bothretraction of the delivery device and steering of the catheter into asubstantially neutral position as the distal end of the delivery deviceexits the atrium. Following removal of the delivery device from theatrium, the delivery catheter may be fully extracted from the patientback along the surgical route used during insertion.

XXVII. Illustrative Aspects of the Present Disclosure

Illustrative examples of the disclosure include, but are not limited tothe following:

Aspect 1-1. A delivery tool for an implantable medical device includinga handle body; a threaded shaft extending within the handle body; ashuttle threadedly engaged with the threaded shaft and configured totranslate along the threaded shaft in response to rotation of thethreaded shaft; a gear assembly driveable by rotating the threadedshaft; a spool coupled to the gear assembly such that the spool isrotatable in response to rotation of the threaded shaft andsimultaneously with translation of the shuttle; a control arm shaftcoupled to the shuttle and extending distally from the handle body, thecontrol arm shaft translatable by translating the shuttle; and a controlarm assembly coupled to a distal end of the control arm shaft, whereinthe control arm assembly is laterally expandable in response totranslation of the control arm shaft.

Aspect 1-2. The delivery tool of Aspect 1-1 further including anextension member extending distally relative to the distal end of thecontrol arm shaft, wherein the control arm assembly further includes: aproximal control arm coupled to a distal end of the control armassembly; and a distal control arm, wherein: a proximal end of thedistal control arm is coupled to the proximal control arm at a couplinglocation, and a distal end of the distal control arm is coupled to adistal end of the extension member.

Aspect 1-3. The delivery tool of Aspect 1-1 further including at leastone cinch line coupled to the spool and extending distally from thehandle body such that rotation of the spool results in a change inlength of the cinch line extending from the spool.

Aspect 1-4. The delivery tool of Aspect 1-1 further including aplurality of cinch lines coupled to the spool and extending distallyfrom the handle body such that rotation of the spool results in asimultaneously change in length of each of the plurality of cinch linesextending from the spool.

Aspect 1-5. The delivery tool of Aspect 1-1, wherein the gear assemblyincludes a worm gear coupled to the threaded shaft and a worm wheelengaged with the worm gear and coupled to the spool.

Aspect 1-6. The delivery tool of Aspect 1-1 further including a userinput actuatable to rotate the threaded shaft.

Aspect 1-7. The delivery tool of Aspect 1-6, wherein the user input is aknob coupled to a proximal end of the threaded shaft.

Aspect 1-8. The delivery tool of Aspect 1-1, wherein the threaded shaftis a first threaded shaft and the delivery tool further includes asecond threaded shaft configured to simultaneously translate each of thegear assembly, the shuttle, and the threaded shaft.

Aspect 1-9. The delivery tool of Aspect 1-8 further including a gearassembly shuttle coupled to the gear assembly and threadedly engagedwith the second threaded shaft, the gear assembly shuttle configured tomove along the second threaded shaft in response to rotation of thesecond threaded shaft.

Aspect 1-10. The delivery tool of Aspect 1-8 further including a firstuser input actuatable to rotate the first threaded shaft and a seconduser input actuatable to rotate the second threaded shaft.

Aspect 1-11. The delivery tool of Aspect 1-8, wherein the first userinput is a first knob coupled to a proximal end of the first threadedshaft and the second user input is a second knob coupled to a proximalend of the second threaded shaft.

Aspect 2-1. A delivery tool for an implantable medical device including:a handle body; a threaded shaft extending within the handle body; ashuttle threadedly engaged with the threaded shaft and configured totranslate along the threaded shaft in response to rotation of thethreaded shaft; an extension shaft coupled to the shuttle and extendingdistally from the handle body, the extension shaft translatable bytranslating the shuttle; and a control arm assembly coupled to a distalend of the control arm shaft, wherein the control arm assembly islongitudinally translatable in response to translation of the extensionshaft and laterally expandable independent of being longitudinallytranslated by the extension shaft.

Aspect 2-2. The delivery tool of Aspect 2-1 further including anextension member coupled to and extending distally from the extensionshaft.

Aspect 2-3. The delivery tool of Aspect 2-2, wherein the control armassembly further includes each of a proximal control arm and a distalcontrol arm, wherein: a proximal end of the distal control arm iscoupled to the proximal control arm at a coupling location, and theproximal control arm is drivable to laterally translate the couplinglocation, thereby selectively expanding the control arm assembly.

Aspect 2-4. The delivery tool of Aspect 2-1 further including anexpansion assembly configured to drive expansion and collapse of thecontrol arm assembly independent of longitudinally translating thecontrol arm assembly.

Aspect 2-5. The delivery tool of Aspect 2-4, wherein longitudinallytranslating the control arm assembly further longitudinally translatesthe expansion assembly.

Aspect 3-1. A delivery tool for an implantable medical device including:a handle body; a frame element supported by the handle body, the frameelement defining an aperture and having a longitudinal axis extendingthrough the aperture; a control ring defining a ring orifice andsupported by the frame element, wherein the control ring is rotatableabout the longitudinal axis and includes a line coupling location; and aprotrusion extending into the ring orifice at a radial offset from thelongitudinal axis, wherein the protrusion is configured to interferewith a control line extending from the aperture to the line couplinglocation following a rotation of the control ring.

Aspect 3-2. The delivery tool of Aspect 3-1 further including a lockconfigured to selectively prevent rotation of the control ring relativeto the frame element.

Aspect 3-3. The delivery tool of Aspect 3-1, wherein: the line couplinglocation is a first line coupling location, the control ring includes asecond release line coupling location angularly offset from the firstrelease line coupling location; and the protrusion is further configuredto interfere with a second control line extending from the aperture tothe second line coupling location in response to a further rotation ofthe control ring.

Aspect 3-4. The delivery tool of Aspect 3-3 further including the firstcontrol line and a retention element, wherein the first control line iscoupled to the retention element such that interference of the firstcontrol line with the protrusion results in proximal retraction of theretention element.

Aspect 3-5. The delivery tool of Aspect 3-4 further including a cinchline, wherein the retention element is configured to retain a distal endof the cinch line prior to proximal retraction of the retention elementand to release the distal end of the cinch line when retracted.

Aspect 3-6. The delivery tool of Aspect 3-5, wherein the cinch line isone of a plurality of cinch lines and the retention element isconfigured to retain each of the plurality of cinch lines prior toproximal retraction of the retention element and to release each of theplurality of cinch lines when retracted.

Aspect 3-7. The delivery tool of Aspect 3-3 further including the secondcontrol line and a cinch line, wherein the second control line isconfigured such that interference of the second release line with theprotrusion results in proximal retraction of the cinch line.

Aspect 3-8. The delivery tool of Aspect 3-7, wherein the cinch line isconfigured to be routed about a portion of the implantable medicaldevice to distribute forces about the implantable medical device duringat least one of expansion and contraction of the implantable medicaldevice.

Aspect 3-9. The delivery tool of Aspect 3-3 further including the secondrelease line and a plurality of cinch lines, wherein the second releaseline is configured to proximally retract each cinch line of theplurality of cinch lines.

Aspect 3-10. The delivery tool of Aspect 3-9, wherein: a proximal end ofeach cinch line of the plurality of cinch lines is anchored within thehandle body, the second release line forms a loop within the handlebody, and each cinch line of the plurality of cinch lines extendsthrough the loop such that retraction of the second release lineproximally retracts each of the plurality of cinch lines.

Aspect 4-1. A delivery tool for an implantable medical device including:a handle body;

a tubular body extending distally from the handle body; and a controlarm assembly coupled to a distal end of the tubular body, wherein: thecontrol arm assembly is selectively expandable in a lateral direction,and the tubular body includes a proximal steerable section and a distalsteerable section, the proximal steerable section being independentlysteerable from the distal steerable section.

Aspect 4-2. The delivery tool of Aspect 4-1, wherein the distalsteerable section is steerable along a first plane and the proximalsteerable section is steerable along each of the first plane and asecond plane orthogonal to the first plane.

Aspect 4-3. The delivery tool of Aspect 4-1 further including anextension tube disposed within the tubular body and configured tolongitudinally translate independent of the tubular body to selectivelyextend the control arm assembly relative to the tubular body, whereinthe extension tube includes an extension tube section having modifiedflexibility with respect to bending along a steering plane of thetubular body.

Aspect 4-4. The delivery tool of Aspect 4-3, wherein the extension tubesection includes a plurality of longitudinal cuts extending along theextension tube section and perpendicular to the steering plane.

Aspect 4-5. The delivery tool of Aspect 4-3, wherein the extension tubesection includes a helical cut extending along the extension tubesection.

Aspect 4-6. The delivery tool of Aspect 4-1 further including anextension tube disposed within the tubular body and configured tolongitudinally translate independent of the tubular body to selectivelyextend the control arm assembly relative to the tubular body, wherein:the distal steerable section is steerable along a first plane, theproximal steerable section is steerable along each of the first planeand a second plane orthogonal to the first plane, the extension tubeincludes a distal extension tube section having modified flexibilitywith respect to bending along the first plane, the extension tubeincludes a proximal extension tube section having modified flexibilitywith respect to bending along each of the first plane and the secondplane.

Aspect 4-7. The delivery tool of Aspect 4-6, wherein the distalextension tube section includes a plurality of longitudinal cutsextending along the distal extension tube section and perpendicular tothe first plane.

Aspect 4-8. The delivery tool of Aspect 4-6, wherein the proximalextension tube section includes a helical cut extending along theextension tube section.

Aspect 4-9. The delivery tool of Aspect 4-3, wherein the extension tubeis formed from nitinol.

Aspect 5-1. A cardiac valve repair implant including: a centraloccluder; a frame extending about a central longitudinal axis from thecentral occluder and self-biasing from a collapsed state to an expandedstate, the frame including: an inner frame portion supporting thecentral occluder; a plurality of spokes extending proximally from thecentral portion and forming a circumference about the centrallongitudinal axis; and expandable outer cells disposed between adjacentspokes of the plurality of spokes; and an outer sheet supported on aproximal portion of the frame and extending circumferentially about theproximal portion of the frame, wherein when the frame is in the expandedstate, the outer sheet and the central occluder define an annulusbetween the outer sheet and the central occluder centered about thecentral longitudinal axis.

Aspect 5-2. The cardiac valve repair implant of Aspect 5-1, wherein theouter sheet is formed from a knit polyethylene terephthalate material.

Aspect 5-3. The cardiac valve repair implant of Aspect 5-1, wherein adistal edge of the outer sheet is circular about the centrallongitudinal axis.

Aspect 5-4. The cardiac valve repair implant of Aspect 5-1, wherein aproximal edge of the outer sheet is sinusoidal.

Aspect 5-5. The cardiac valve repair implant of Aspect 5-1, wherein aproximal edge of the outer sheet varies between a first proximal extendand a second proximal extent different than the first proximal extent.

Aspect 5-6. The cardiac valve repair implant of Aspect 5-1, wherein theouter sheet is coupled to the frame by one or more hems.

Aspect 5-7. The cardiac valve repair implant of Aspect 5-6, wherein theouter sheet is coupled to the frame by a first hem extending along aproximal edge of the frame and a second hem extending about a proximaledge of the annulus.

Aspect 5-8. The cardiac valve repair implant of Aspect 5-1, wherein eachof the expandable outer cells includes a proximal tip and a distal tipand wherein a suture is wrapped about at least one of the proximal tipand the distal tip.

Aspect 6-1. A cardiac valve repair implant including: a central occluderincluding a central longitudinal axis; a frame extending from thecentral occluder, the frame including a central portion supporting thecentral occluder and a plurality of spokes extending from the centralportion and distributed circumferentially about the central longitudinalaxis; an outer sheet supported on a proximal portion of the frame andextending circumferentially about the proximal portion of the frame; anda plurality of eyelets distributed circumferentially about the centrallongitudinal axis, each eyelet of the plurality of eyelets coupled toand extending from a respective spoke of the plurality of spokes.

Aspect 6-2. The cardiac valve repair implant of Aspect 6-1, wherein theouter sheet is retained on an outer side of the frame and the pluralityof eyelets extend opposite the outer sheet.

Aspect 6-3. The cardiac valve repair implant of Aspect 6-1, wherein aspoke of the plurality of spokes defines a slot through which an eyeletof the plurality of eyelets extends.

Aspect 6-4. The cardiac valve repair implant of Aspect 6-3, wherein: theeyelet includes a body portion defining a through hole and a shankportion coupled to the body portion, the shank portion has a widthgreater than the body portion, and the eyelet is received by the slotsuch that the body portion extends through the slot to a first side ofthe spoke and the shank is retained on a second side of the spokeopposite the first side.

Aspect 6-5. The cardiac valve repair implant of Aspect 6-3, wherein theeyelet defines a retention hole and the eyelet is coupled to the frameby a suture loop extending through the retention hole and around theframe.

Aspect 6-6. The cardiac valve repair implant of Aspect 6-1, wherein eachof eyelets includes a radiused through hole.

Aspect 7-1. A cardiac valve repair implant comprises: a central occluderincluding a central longitudinal axis; a frame extending proximally fromthe central occluder, the frame centered about and forming acircumference around the central longitudinal axis of the centraloccluder and self-biasing from a collapsed state to an expanded state;and an outer sheet supported on a proximal portion of the frame, whereinwhen the frame is in the expanded state, the outer sheet forms anannular surface defining an inner circular opening centered about thecentral longitudinal axis of the central occluder, wherein: the frameincluding an inner portion coupled to and supporting the centraloccluder, and the central occluder has a laminated constructionincluding a first sheet disposed on a distal side of the inner frameportion coupled to a second sheet disposed on a proximal side of theinner frame portion.

Aspect 7-2. The cardiac valve repair implant of Aspect 7-1 wherein thecentral occluder has a distally concave shape.

Aspect 7-3. The cardiac valve repair implant of Aspect 7-1, wherein thefirst sheet is formed from a substantially impermeable material.

Aspect 7-4. The cardiac valve repair implant of Aspect 7-3, wherein thesecond sheet is formed from a permeable material.

Aspect 7-5. The cardiac valve repair implant of Aspect 7-4, wherein thesecond sheet is bonded to the first sheet by a liquid bonding materialapplied to the second sheet.

Aspect 7-6. The cardiac valve repair implant of Aspect 7-1, wherein thefirst sheet is formed from expanded polytetrafluoroethylene (ePTFE).

Aspect 7-7. The cardiac valve repair implant of Aspect 7-1, wherein thesecond sheet is formed from a fabric.

Aspect 7-8. The cardiac valve repair implant of Aspect 7-7, wherein thefabric including woven polyethylene terephthalate (PET).

Aspect 7-9. The cardiac valve repair implant of Aspect 7-1, wherein thefirst sheet is coupled to the second sheet using a polyurethanecompound.

Aspect 7-10. The cardiac valve repair implant of Aspect 7-9, wherein thepolyurethane compound including a siloxane segmented polyurethane and apolymer precursor.

Aspect 7-11. The cardiac valve repair implant of Aspect 7-10, whereinthe polymer precursor is such as tetrahydrofuran (THF).

Aspect 7-12. The cardiac valve repair implant of Aspect 7-1, wherein thecentral occluder further comprises a proximal cap.

Aspect 7-13. The cardiac valve repair implant of Aspect 7-12, whereinthe proximal cap including a frame element and a proximal sheet coupledto the frame element.

Aspect 7-14. The cardiac valve repair implant of Aspect 7-13, whereinthe proximal sheet is formed from a porous material.

Aspect 7-15. The cardiac valve repair implant of Aspect 7-12, whereinthe proximal cap has a distally convex shape.

Aspect 7-16. The cardiac valve repair implant of Aspect 7-12, whereinthe proximal cap and the second sheet define an internal volume of thecentral occluder.

Aspect 7-17. The cardiac valve repair implant of Aspect 7-16, whereinthe internal volume is filled with aa solid or expandable material.

Aspect 7-18. The cardiac valve repair implant of Aspect 7-12, whereinthe proximal cap is coupled to at least one of the first sheet and thesecond sheet by a suture extending around the circumference of thecentral occluder.

XXVIII. Conclusion

While the present disclosure has been described with reference tovarious implementations, it will be understood that theseimplementations are illustrative and that the scope of the presentdisclosure is not limited to them. Many variations, modifications,additions, and improvements are possible. More generally, embodiments inaccordance with the present disclosure have been described in thecontext of particular implementations. Functionality may be separated orcombined in blocks differently in various embodiments of the disclosureor described with different terminology. These and other variations,modifications, additions, and improvements may fall within the scope ofthe disclosure as defined in the claims that follow.

In general, while the embodiments described herein have been describedwith reference to particular embodiments, modifications can be madethereto without departing from the spirit and scope of the disclosure.Note also that the term “including” as used herein is intended to beinclusive, i.e. “including but not limited to.”

The construction and arrangement of the systems and methods as shown inthe various exemplary embodiments are illustrative only. Although only afew embodiments have been described in detail in this disclosure, manymodifications are possible (e.g., variations in sizes, dimensions,structures, shapes and proportions of the various elements, values ofparameters, mounting arrangements, use of materials, colors,orientations, etc.). For example, the position of elements may bereversed or otherwise varied and the nature or number of discreteelements or positions may be altered or varied. Accordingly, all suchmodifications are intended to be included within the scope of thepresent disclosure. The order or sequence of any process or method stepsmay be varied or re-sequenced according to alternative embodiments.Other substitutions, modifications, changes, and omissions may be madein the design, operating conditions and arrangement of the exemplaryembodiments without departing from the scope of the present disclosure.

We claim:
 1. A delivery device for cardiac valve repair implants, thedelivery device comprising: a delivery catheter; an extension memberprotruding from a distal end of the delivery catheter; and a control armassembly releasably coupleable to a valve repair implant, the controlarm assembly including a control arm pair, wherein the control arm pairincludes: a distal control arm coupled to and extending proximally froma distal end of the extension member; and a proximal control arm coupledthe distal control arm, the proximal control arm extendable from thedistal end of the delivery catheter to laterally expand the control armassembly.
 2. The delivery device of claim 1, wherein the control armpair is one of a plurality of control arm pairs of the control armassembly, each control arm pair including a respective distal controlarm and a respective proximal control arm.
 3. The delivery device ofclaim 2, wherein each proximal control arm of each control arm pair issimultaneously extendable from the distal end of the delivery catheterto laterally expand the control arm assembly.
 4. The delivery device ofclaim 2, further comprising a control arm shaft disposed within thedelivery catheter, wherein: the control arm shaft is coupled to aproximal portion of the control arm assembly and is translatablerelative to the delivery catheter, and each proximal control arm of eachcontrol arm pair is simultaneously extendable from the distal end of thedelivery catheter to laterally expand the control arm assembly bytranslating the control arm shaft.
 5. The delivery device of claim 1,further comprising a control assembly coupled to a proximal end of thedelivery catheter and a control arm extension member shaft extendingthrough the delivery catheter and coupled to the proximal control arm,the control assembly including a control for selectively extending andretracting the proximal control arm by translating the control armextension member shaft.
 6. The delivery device of claim 1, furthercomprising a diverter disposed distal the distal end of the deliverycatheter, wherein the diverter directs the proximal control armlaterally as the proximal control arm is extended from the distal end ofthe delivery catheter.
 7. The delivery device of claim 1, wherein thedistal control arm is rigidly coupled to the distal end of the extensionmember such that, as the proximal control arm is extended from thedistal end of the delivery catheter, the distal control arm bendslaterally.
 8. The delivery device of claim 1, wherein the extensionmember is selectively extendable from the distal end of the deliverycatheter.
 9. The delivery device of claim 8 further comprising a controlassembly coupled to a proximal end of the delivery catheter, the controlassembly including a control for selectively extending and retractingthe extension member from the distal end of the delivery catheter. 10.The delivery device of claim 1 further comprising a control assemblycoupled to a proximal end of the delivery catheter and an extensionmember shaft extending through the delivery catheter and coupled to theextension member, the control assembly including a knob rotatable toselectively extend and retract the proximal control arm by translatingthe extension member shaft.
 11. The delivery device of claim 1 furthercomprising a sheath disposed about the delivery catheter, wherein thesheath is translatable from a first position in which the sheath extendsover the extension member and a second position in which the extensionmember is at least partially exposed.
 12. The delivery device of claim1, wherein: the delivery catheter includes a first steerable portion anda second steerable portion, the first steerable portion is distal thesecond steerable portion, and the first steerable portion is steerableindependent of the second steerable portion.
 13. The delivery device ofclaim 12, wherein the first steerable portion and the second steerableportion are steerable along a common plane.
 14. The delivery device ofclaim 13, wherein the second steerable portion is further steerablealong a second plane orthogonal to the common plane.
 15. The deliverydevice of claim 1, wherein the proximal control arm is coupled to aproximal end of the distal control arm.
 16. The delivery device of claim1, wherein the proximal control arm is coupled to a location of thedistal control arm within a proximal half of the distal control arm. 17.The delivery device of claim 1, wherein the distal control arm includesa distal curvate section that is distally concave and a proximal curvatesection that is proximally concave.
 18. The delivery device of claim 1further comprising at least one cinch line extending through thedelivery catheter and selectively retractable and extendable relative tothe delivery catheter.
 19. The delivery device of claim 18 furthercomprising a control assembly coupled to a proximal end of the deliverycatheter, the control assembly including a control for each ofsimultaneously expanding the control arm assembly and paying out the atleast one cinch line and simultaneously collapsing the control armassembly and retracting the at least one cinch line.
 20. A deliverydevice for cardiac valve repair implants, the delivery devicecomprising: a delivery catheter; an extension member protruding from adistal end of the delivery catheter; and a control arm assemblyreleasably coupleable to a valve repair implant, the control armassembly including a plurality of control arm pairs distributedcircumferentially about the extension member, wherein each control armpair of the plurality of control arm pairs includes: a distal controlarm coupled to and extending proximally from a distal end of theextension member; and a proximal control arm coupled to the distalcontrol arm, the proximal control arm extendable from the distal end ofthe delivery catheter to laterally expand the control arm assembly. 21.The delivery device of claim 20, further comprising a control armextension member shaft extending through the delivery catheter andcoupled to each proximal control arm of the plurality of control armpairs, wherein the control arm extension member shaft is selectivelytranslatable relative to the delivery catheter to expand and contractthe control arm assembly.
 22. The delivery device of claim 20 furthercomprising at least one cinch line extending through the deliverycatheter and selectively retractable and extendable relative to thedelivery catheter.
 23. The delivery device of claim 22 furthercomprising a control assembly coupled to a proximal end of the deliverycatheter, the control assembly including a control for each ofsimultaneously expanding the control arm assembly and paying out the atleast one cinch line and simultaneously collapsing the control armassembly and retracting the at least one cinch line.
 24. The deliverydevice of claim 20, wherein: the delivery catheter includes a firststeerable portion and a second steerable portion, the first steerableportion is distal the second steerable portion, the first steerableportion is steerable independent of the second steerable portion, eachof the first steerable portion and the second steerable portion aresteerable along a common plane; and the second steerable portion isfurther steerable along a second plane orthogonal to the common plane.25. A delivery device for cardiac valve repair implants, the deliverydevice comprising: a delivery catheter; an extension member protrudingfrom a distal end of the delivery catheter; and a control arm assemblyreleasably coupleable to a valve repair implant, the control armassembly including a control arm pair, wherein the control arm pairincludes: a distal control arm coupled to and extending proximally froma distal end of the extension member; and a proximal control arm coupledto a proximal portion of the distal control arm, the proximal controlarm extendable from the distal end of the delivery catheter to laterallyexpand the control arm assembly, wherein the delivery catheter includesa distal portion including a plurality of independently steerablesections.
 26. The delivery device of claim 25, wherein the plurality ofindependently steerable sections includes a first steerable section anda second steerable section and each of the first steerable section andthe second steerable section is steerable along a common plane.
 27. Thedelivery device of claim 26, wherein the first steerable section isdistal the second steerable section and the second steerable section isfurther steerable along a second plane orthogonal to the common plane.28. The delivery device of claim 25, wherein the control arm pair is oneof a plurality of control arm pairs of the control arm assembly, eachcontrol arm pair including a respective distal control arm and arespective proximal control arm.
 29. The delivery device of claim 28,further comprising a control arm shaft disposed within the deliverycatheter, wherein: the control arm shaft is coupled to a proximalportion of the control arm assembly and is translatable relative to thedelivery catheter, and each proximal control arm of each control armpair is simultaneously extendable from the distal end of the deliverycatheter to laterally expand the control arm assembly by translating thecontrol arm shaft.
 30. The delivery device of claim 25, wherein theextension member is selectively extendable from the distal end of thedelivery catheter.